Merit Medical CC-1301 User Manual

INSTRUCTIONS FOR USE

REPLACEMENT
CONNECTOR & CAP KIT
CC-1301

For Flex-Neck® Adult, Adolescent & Pediatric
Peritoneal Dialysis Catheters ONLY

REPLACEMENT
CONNECTOR & CAP KIT
CC-1301 English

For Flex-Neck® Adult, Adolescent & Pediatric
Peritoneal Dialysis Catheters ONLY

PRODUCT DESCRIPTION

Replacement Connector and Cap Kit for Flex-Neck® Adult,
Adolescent, and Pediatric Peritoneal Dialysis Catheter.

Each pouch contains one Connector and one Cap.

• Tapered Tip (A) A

• Raised Shoulder Ridge (B)

• Finger Grip (C) C B

• Threaded Luer (D)

• Cap (E) E

INDICATIONS FOR USE

The Replacement Connector and Cap are indicated ONLY
for Flex-Neck Adult, Adolescent, and Pediatric Peritoneal
Dialysis Catheters, to be used when a patient needs a
replacement connector and cap.

CONTRAINDICATIONS FOR USE

Do NOT use with Flex-Neck Infant Peritoneal Dialysis
Catheters. Do NOT use with other peritoneal dialysis
catheter brands.

Px Only: CAUTION: Federal (USA) law restricts this device
to sale by or on the order of a physician.

PRECAUTIONS

• Read manufacturer’s instructions prior to use.

• Contents are sterile (via ethylene oxide). Do not use if
packaging is opened, damaged or broken.

• For single patient use only. Do not reuse, reprocess, or
resterilize. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device and/
or lead to device failure, which in turn may result in
patient injury, illness, or death. Reuse, reprocessing or
resterilization may also create a risk of contamination
of the device and/or cause patient infection or cross­ infection, including, but not limited to, the transmission
of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness,
or death of the patient.

• Do not use after expiration date.

• The medical techniques, procedures, and potential
complications stated herein do NOT give full and/or
complete coverage or descriptions. They are not a
substitute for adequate training and sound medical
judgment by a physician.

• Use an aseptic procedure to open the package and to
remove the contents.

POTENTIAL COMPLICATIONS

• Infections (exit-site or tunnel)

• Peritonitis

• Sepsis

• Leakage (initial or latent)

• Catheter separation from the connector

CAUTIONS

• Catheter tubing can tear when subjected to repeated
clamping, serrated-jaw forceps, excessive force,
or rough tools.

• Do NOT use forceps with a serrated jaw.

• Do NOT use excessive force to lock the forceps closed.

• Use ONLY smooth-jawed forceps or equivalent.

• Do NOT clamp the catheter repeatedly in the same area.

• Do NOT clamp near the connector.

D

INSTRUCTIONS FOR USE

1. Create a sterile eld for the procedure:

• Prepare the patient’s skin and catheter with a cleaning
or disinfecting solution as needed per hospital protocol.

• Drape the catheter exit-site area in an appropriate
manner.

2. If clamping the catheter tubing with sterile hemostats or
forceps, use only smooth-jawed forceps or equivalent. Do
not use forceps with a serrated jaw as damage may occur.
See cautions.

3. Prepare the existing Flex-Neck Catheter:

• Cut catheter tubing just distal to the existing connector
with sterile suture scissors, in a single, straight,
perpendicular cut. Do not pull the connector o the
catheter.

• There must be at least 2.5 cm of catheter tubing
remaining after trimming.

• Verify that the cut is perpendicular to the tubing.

4. Wet the tapered tip (A) of the Replacement Connector
with sterile saline or sterile water, and insert it into the
catheter.

• Do not use any other lubricant.

• Do not use a twisting motion to force the catheter onto
the Replacement Connector.

5. Push the connector into the catheter with a single
forward motion.

6. Advance the catheter completely to the raised shoulder
ridge of the Replacement Connector.

NOTE: The catheter tubing must completely pass over
the tapered tip and to the raised shoulder ridge, but not
beyond that onto the nger grip. See diagram above.

7. Pull carefully on the Replacement Connector and
catheter to test the strength of the connection.

8. Attach either the Cap or a dialysis transfer set, to the
threaded luer.

CAThETER CLEANINg AND CARE

All Flex-Neck Peritoneal Dialysis Catheters are made of
silicone. Exit-site cleaning agents that are compatible with
silicone catheters therefore may be acceptable for use
on Flex-Neck Peritoneal Dialysis Catheters. Such cleaning
agents include:

• Electrolytically-produced sodium hypochlorite solutions
(i.e., ExSept Plus®)

• Normal (sterile) saline

Cleaning agents that are non-irritating, non-toxic, anti­bacterial, and in liquid form are generally recommended.

The following cleaning agents are not compatible with
silicone catheters, and are not recommended for use with
Flex-Neck Peritoneal Dialysis catheters:

• Acetone or acetone-based products

• Povidone-iodine or iodine-based products

Merit Medical Systems, does not provide specic recom­mendations or protocols for exit-site care and cleaning,
whether by the healthcare professional or by the patient.
Appropriate exit-site and catheter care treatment protocols
should be individualized for each patient, and established
by the patient’s physician(s), nurse(s), dialysis center(s),
and/or other relevant dialysis healthcare professionals.