Bard Groshong NXT PICC User manual

Instructions For Use

Table of Contents
Table of Contents
Page Contents
1Product Description
2Product Description, Indications & Contraindications
3Contraindications, Warnings & Precautions
4Precautions
5Precautions & Possible Complications
6Insertion Instructions
1. Identify the Vein and Insertion Site
2. Patient Position/ Catheter Measurement
3. Preflush the Catheter
4. Prepare for Insertion
5. Apply Tourniquet and Drape
6. Perform Venipuncture
7. Withdraw the Introducer Needle
8. Insert and Advance the Catheter
9. Complete Catheter Insertion
10. Retract Introducer. Remove Splitable Introducer
11. Attach Suture Wings (Dual Lumen Only)
12. Remove the Stylet/Assembly
13. Remove Non-Splitable Introducer
14. Modification of Catheter Length (SL Only)
15. Attach Connector to SL Catheters
16. Aspirate and Flush
17. Verify Placement
18. Securing the Groshong Catheter
16 Suggested Catheter Maintenance and Catheter Removal

Product Description
Groshong*NXT peripherally inserted Central Catheters are made from
specially formulated and processed medical grade materials, in a tray with
accessories for reliable long (greater than 30 days) or short (less than 30
days) term vascular access.
Groshong*Valve Function
The Groshong*catheter incorporates
the patented, 3-position, pressure-sensi-
tive Groshong*valve. The valve is located near the rounded, closed,
radiopaque catheter tip and allows fluid infusion and blood aspiration.
When not in use, the valve restricts blood backflow and air embolism by
remaining closed.
The Groshong*valve is designed to remain closed between -7 and 80 mm
Hg. Since the normal central venous pressure range in the superior vena
cava is 0 to 5 mm Hg, the valve remains closed at normal central venous
pressure. Pressure in the superior vena cava must exceed 80 mm Hg to
open the valve inward. Also, negative pressure (vacuum) will cause the
valve to open inward, allowing blood aspiration.
Positive pressure into the catheter (gravity, pump, syringe) will open the
valve outward, allowing fluid infusion. The need for the anticoagulant effect
of heparin is eliminated because the closed valve prevents blood from
entering the catheter and clotting. If the catheter is aspirated, pulling the
valve inward, it must be flushed with normal saline to clear blood from the
lumen and allow the valve to return to its normal closed position.
Product Description
• The Groshong NXT dual-lumen catheter features a reverse-taper catheter design.
•For Superior Vena Cava (SVC) placement, measure from the planned insertion
site to the right clavicular head, then down to the third intercostal space. Use the
45 or 55cm mark as reference for point of insertion.
•Catheter does not require “s” curve for dress-
ing and securement.
Reverse
Taper
CLOSED
Neutral Pressure
ASPIRATION
Negative Pressure INFUSION Positive Pressure
1
Dual Lumen

The benefits provided by the Groshong*valve are:
1. Increased patient safety due to reduced risk of air embolism or
bleedback.
2. Elimination of the need for heparin flushing to maintain catheter
patency.
3. Reduced need for catheter clamping.
4. Reduced need for flushing when the catheter is not in use.
Groshong*NXT dual-lumen catheters have Groshong*valves which
are rotated and staggered, allowing the simultaneous infusion of
incompatible drugs. Refer to the appropriate drug labeling for indica-
tions, contraindications, warnings, precautions, dosage and administra-
tion information. Each lumen of a dual-lumen catheter is treated sepa-
rately for maintenance and irrigation purposes.
Indications
The Groshong*NXT PICC provides short (less than 30 days) or long
(greater than 30 days) term peripheral access to the central venous
system for intravenous therapy or blood sampling.
Contraindications:
The Groshong*NXT PICC is contraindicated whenever:
•The presence of device related infection, bacteremia, or septicemia
is known or suspected.
•The patient’s body size is insufficient to accommodate the size of
the implanted device.
•Past irradiation of prospective insertion site.
•Previous episodes of venous thrombosis or vascular surgical procedures at
the prospective placement site.
•Local tissue factors will prevent proper device stabilization
and/or access.
ChloraPrep*One-Step Applicator Contraindications:
•Do not use in children less than 2 months of age because of the potential for
excessive skin irritation and increased drug absorption.
•Do not use on patients with known allergies to chlorhexidine gluconate or
isopropyl alcohol.
Product Description, Indications &
Contraindications
2

•Do not use for lumbar puncture or in contact with meninges.
•Do not use on open skin wounds or as a general skin cleanser.
Warnings:
Groshong*NXT PICC
•Intended for Single Patient Use. DO NOT REUSE. Bard Access Systems,
Inc. products are single use devices and should never be reimplanted.
Reuse carries with it the attendant concern of cross-infection regardless of
the cleaning or sterilization method. Resterilization of incompletely cleaned
devices may not be effective. Any device that has been contaminated by
blood should not be reused or resterilized.
•This is not a right atrium catheter. Avoid positioning the catheter tip in the
right atrium. Placement or migration of the catheter tip into the right atrium
may cause cardiac arrhythmia, myocardial erosion or cardiac tamponade.The
risk of these complications may be more likely in neonatal patients.
•After use, this product may be a potential biohazard. Handle and discard in
accordance with accepted medical practice and applicable local, state and
federal laws and regulations.
ChloraPrep*One-Step Applicator
•Flammable, keep away from fire or flame.
•Do not use with electrocautery procedures.
•For external use only.
•When using this product keep out of eyes, ears, and mouth. May cause seri-
ous or permanent injury if permitted to enter and remain. If contact occurs,
rinse with cold water right away and contact a physician.
•Stop use and ask a doctor if irritation, sensitization, or allergic reaction
occurs. These may be signs of a serious condition.
•Keep out of reach of children. If swallowed, get medical help or contact a
poison control center right away.
Precautions:
• Carefully read and follow all instructions prior to use.
•Caution: Federal (U.S.A.) law restricts this device to sale by or on the order
of a physician.
• Only qualified healthcare practitioners should insert, manipulate and remove
these devices.
• To minimize the risk of catheter breakage and embolization, the suture wing
and / or adapter must be secured in place.
Contraindications, Warnings &
Precautions
3

• Never use force to remove the stylet. Resistance can damage the catheter. If
resistance or bunching of the catheter is observed, stop stylet withdrawal
and allow the catheter to return to normal shape. Withdraw both the catheter
and stylet together approximately 2 cm and reattempt stylet removal. Repeat
this procedure until the stylet is easily removed.
• To reduce potential for blood backflow into the catheter tip, always remove
needles or needleless caps slowly while injecting the last 0.5 ml of saline.
•Follow Universal Precautions when inserting and maintaining the catheter.
•Follow all contraindications, warnings, precautions and instructions for all
infusates as specified by its manufacturer.
•Use aseptic techniques whenever the catheter lumen is opened or connected
to other devices. Chlorhexidine gluconate is the suggested antiseptic to use.
Acetone and tincture of iodine should not be used. 2% Chlorhexidine glu-
conate /70% isopropyl alcohol swabsticks may be used for dressing changes.
Povidone-iodine may also be used as an antiseptic.
•The fluid level in the catheter will drop if the catheter connector is held above
the level of the patient’s heart and opened to air. To help prevent a drop in the
fluid level (and thus air entry) while changing injection caps, hold the connec-
tor below the level of the patient’s heart before removing the injection cap.
•Examine the package carefully before opening to confirm its integrity and that
the expiration date has not passed. The device is supplied in a sterile pack-
age and is non-pyrogenic. Do not use if package is damaged, opened or the
expiration date has passed. Sterilized by ethylene oxide. Do not Resterilize.
•Inspect kit for inclusion of all components.
•Flush the catheter with sterile normal saline prior to use.
•Avoid accidental device contact with sharp instruments and mechanical damage
to the catheter material. Use only smooth-edged atraumatic clamps or forceps.
•Avoid perforating, tearing or fracturing the catheter when using a guidewire.
•Do not use the catheter if there is any evidence of mechanical damage or
leaking.
•Avoid sharp or acute angles during implantation which could compromise the
patency of the catheter lumen(s).
II. To avert device damage and/or patient injury during placement.
I. Prior to beginning placement procedure, do the following:
4
Precautions

•Use suture wings to secure the catheter without compromising catheter
patency.
•Do not place sutures around catheter.
•Do not use the device if there is any evidence of mechanical damage or leak-
ing. Damage to the catheter may lead to rupture, fragmentation and possible
embolism and surgical removal.
•Accessories and components used in conjunction with this device should
incorporate Luer lock connections.
•If signs of extravasation exist, discontinue injections. Begin appropriate med-
ical intervention immediately.
•Infusion pressure greater than 25 psi (172 kPa) may damage blood vessels
and viscus and is not recommended. DO NOT USE A SYRINGE SMALLER
THAN 10 ml!
• For those unfamiliar with the procedure, published studies and a video are
available from Bard Access Systems, Inc. depicting insertion and mainte-
nance techniques.
• For further information or questions, please call 800-443-3385 or
801-595-0700.
Possible Complications
The potential exists for serious complications including the following:
• Air Embolism • Exit Site Infection • Phlebitis
• Bleeding • Exit Site Necrosis • Spontaneous Catheter
• Brachial Plexus Injury • Extravasation Tip Malposition or Retraction
• Cardiac Arrhythmia • Fibrin Sheath Formation • Thromboembolism
• Cardiac Tamponade • Hematoma • Venous Thrombosis
• Catheter Erosion • Intolerance Reaction to • Ventricular Thrombosis
Through the Skin Implanted Device • Vessel Erosion
• Catheter Embolism • Laceration of Vessels or • Risks Normally Associated
• Catheter Occlusion Viscus with Local or General
• Catheter-related Sepsis • Myocardial Erosion Anesthesia, Surgery and
• Endocarditis • Perforation of Vessels Post Operative Recovery
or Viscus
III. After placement, observe the following precautions to avoid
device damage and/or patient injury:
5
Precautions & Possible Complications

6
Insertion Instructions
Insertion Instructions
1. Identify the Vein and Insertion Site
• Apply a tourniquet above the anticipated
insertion site.
• Select a vein based on patient assess-
ment. Veins of the antecubital fossa are
recommended (basilic, cephalic median
cubital veins) with the basilic preferred.
• Release tourniquet.
2. Patient Position/ Catheter Measurement
• Position the arm at a 90° angle.
• For SVC placement, measure from the planned insertion site over to
the sternal notch, then down to the third intercostal space.
• Note that the external measurement can never exactly duplicate the
internal venous anatomy.

7
Insertion Instructions
3. Preflush the Catheter
4. Prepare for Insertion
• Set-up the sterile field.
• Prepare the site with the ChloraPrep*One-Step Applicator or
according to institutional policy using sterile technique.
- Pinch the wings on the ChloraPrep*One-Step Applicator to break
the ampule and release the antiseptic. Do not touch the
sponge.
- Wet the sponge by repeatedly pressing and releasing the sponge
against the treatment area until fluid is visible on the skin.
- Use repeated back-and-forth strokes of the sponge for
approximately 30 seconds. Completely wet the treatment area
with antiseptic. Allow the area to dry for approximately 30
seconds.
Do not blot or wipe away.
- Maximum treatment area for one applicator is approximately
130cm2 (approximately 4 x 5 in.). Discard the applicator after
a single use.
• Remove and discard gloves.
1
2
3
4
5
1
2
3
4
5
• Attach prefilled syringe to luer
attachment on flushable stylet.
• Preflush catheter with sterile
normal saline or heparinized
saline to wet stylet.
• The syringe may be left
attached during procedure.
• Attach prefilled syringe to the
Luer attachment on the exten-
sion set.
• Preflush catheter with sterile nor-
mal saline or heparinized saline
to wet hydrophilic stylet.
• The syringe may be left attached
during procedure.
Dual
Lumen Single Lumen

5. Apply Tourniquet and Drape
• Apply the tourniquet above the intended insertion site to distend
the vessel.
• Put on sterile non-powdered gloves. Powdered gloves should be
washed before use.
• Drape the patient by placing the fenestrated drape over the
anticipated puncture site.
6. Perform Venipuncture
Splitable
• Remove the needle guard.
• Grip only the needle hub during
insertion. Do not apply excessive
pressure to the T-handles.
• Perform venipuncture and
observe for flashback.
• Holding the needle stationary,
advance the introducer sheath
into the vessel by pushing forward.
8
Insertion Instructions
Non-Splitable
• Remove the needle guard.
• Grip only the needle hub
during insertion.
• Perform venipuncture and
observe for flashback.
• Holding the needle stationary,
advance the introducer sheath
into the vessel by pushing forward.