Bard Groshong PICC User manual

Bard Access Systems
Groshong
*
PICC and
Catheters
Instructions For Use

Table of Contents
Table of Contents
Page Contents
1Product Description
2Product Description, Indications &
Contraindications
3Contraindications,Warnings & Cautions
4Precautions
5Precautions, Possible Complications
6-14 Insertion Instructions
1. Site Selection
2. Length Determination
3. Preflushing Catheter
4. Site Preparation
5. Venipuncture
6. Catheter Insertion
7. Suture Wing Attachment
8. Single Lumen Connection Attachment
9. Placement Verification
10. Securing the Catheter
15 Suggested Catheter Maintenance &
Catheter Removal

Product Description
A family of single and dual-lumen peripherally placed
and central catheters made from specially formulated and processed
medical grade materials, in a tray with accessories for reliable long
(greater than 30 days) or short term (less than 30 days) vascular
access.
Groshong*Valve Function
The Groshong*catheter incorporates the patented, 3-position, pres-
sure-sensitive Groshong*valve. The valve is located near the round-
ed, 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 superi-
or vena cava is 0 to 5 mm Hg, the valve remains closed at normal cen-
tral 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 anticoagu-
lant effect of heparin is eliminated because the closed valve prevents
blood from entering the catheter and clotting. If the catheter is aspirat-
ed, 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
1
CLOSED
Neutral Pressure
ASPIRATION
Negative Pressure INFUSION Positive Pressure

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*multi-lumen catheters have Groshong*valves which are
rotated and staggered, allowing the simultaneous infusion of incompati-
ble drugs. Each lumen of a multi-lumen catheter is treated separately
for maintenance and irrigation purposes.
Indications
The Groshong*PICC catheter is designed for use when central
venous catheterization is prescribed. The Groshong*Midline catheter
is used for peripheral placement for delivery of selected infusates (See
Contraindications). For blood therapy, it is recommended that a 4
French or larger catheter be used.
Contraindications:
The device 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.
•The patient is known or is suspected to be allergic to materials contained in
the 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.
•A midline catheter placement is contraindicated for patients requiring any of
the following:
-Solutions with final glucose concentrations above 10 percent;
Product Description, Indications &
Contraindications
2

-Solutions with protein concentrations above 5 percent;
-Continuous infusion of vesicants.
Warnings:
•Intended for Single Patient Use. DO NOT REUSE. Bard Access Systems
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 potential 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.
Cautions:
• Carefully read and follow all instructions prior to use.
• 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 “Y” adapter must be secured in place.
• 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.
• For those unfamiliar with the procedure, published studies and a video are
available from Bard Access Systems depicting insertion and maintenance
techniques.
• For further information or questions, please call 800-443-3385 or 801-595-0700.
Contraindications, Warnings &
Cautions
3

Precautions:
•Follow Universal Precautions when inserting and maintaining the catheter.
•Follow all contraindications, warnings, cautions, 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. Povidone-iodine is the suggested antiseptic to use. Acetone
and tincture of iodine should not be used. 10% acetone/70% isopropyl alco-
hol swabsticks used for dressing changes may be used.
•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).
•Use suture wings to secure the catheter without compromising catheter
patency.
•Do not place sutures around catheter.
II. To avert device damage and/or patient injury during placement.
I. Prior to beginning placement procedure, do the following:
4
Precautions

•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!
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.
• For midline placement, measure to desired tip location in proximal
portion of extremity, just distal to the shoulder and deltoid muscle.
• Note that the external measurement can never exactly duplicate the
internal venous anatomy.

7
Insertion Instructions
3. Preflush the Catheter
• Attach prefilled syringe to the Luer attach-
ment on the flushing stylet.
• Preflush catheter with sterile normal saline.
• The syringe may be left attached during pro-
cedure.
4. Prepare for Insertion
• Set-up the sterile field.
• Prepare the site according to institution policy using sterile tech-
nique.
5. ApplyTourniquet 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 antici-
pated puncture site.
1
2
3
4
5

6. Perform Venipuncture
• Remove the needle guard.
• Grip only the needle hub during insertion. Do not apply excessive
pressure to the T-handles (if applicable).
• Perform venipuncture and observe for flashback.
• Holding the needle stationary, advance the introducer sheath into
the vessel by pushing forward.
8
Insertion Instructions
1. 2.
3. 4.