Merit Medical PD Catheter Repair Kit IFU - Manual (Page 2)

FLEX-NECK® CATHETER
EXTERNAL REPAIR KIT
CE-1400
English
For Flex-Neck Peritoneal Dialysis Catheters ONLY
PRODUCT DESCRIPTION
• Tube-to-Tube Connector for all Flex-Neck Adult,
Adolescent, and Pediatric Catheters- Sterile Pouch (A)
• Tube-to-Tube Connector for all Flex-Neck Infant
Catheters - Sterile Pouch (B)
• 20 cm of Repair Catheter Tubing (C)
• Catheter Connector (D)
• Cap (E)
INDICATIONS FOR USE
This device is intended for use with Flex-Neck catheters
and Ash Advantage™ catheters in the event one of the two
situations described below should occur:
1. Extender Application
In some patients, the external portion of the PD catheter
may be too short for them to comfortably use. For example,
obese patients may need an extender kit to be able to work
with external part of the catheter. Other patients may re-
quire the external end of the catheter to be more centrally
located than it normally might be.
2. Repair Application
If a peritoneal dialysis catheter develops a fracture in the
external portion, the catheter must be trimmed to elimi-
nate the fracture. Doing so, by definition, will shorten the
catheter and may make it impractical or difficult or even
unsuitable for use. Rather than replace the entire catheter,
it is desirable to retain the catheter by extending the exter-
nal part of the catheter with new tubing.
In either situation, this device enables qualified medical
staff to extend and/or repair the external part of an existing
Flex-Neck catheter or Ash Advantage catheter by adding a
20 cm long tube to the existing and/or remaining catheter
tubing.
CONTRAINDICATIONS FOR USE
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 com-
plications stated herein do NOT give full and/or com-
plete 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
• Follow the specific order of connections as given in the
Instructions for Use. Do not connect the various tubings
and connectors in any other order.
• Use only sterile saline or sterile water as lubricants. Do
not use any other lubricants.
• 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, or repair tubing repeatedly
in the same area.
• Do NOT clamp near the connector.
Cap (E)
Transfer Set
(not included)
Existing Flex-
Neck Adult,
Adolescent,
or Pediatric
Catheter
Existing Flex-
Neck Infant
Catheter
Tube-to-Tube
Connector (A), for
Flex-Neck Adult,
Adolescent, or
Pediatric Catheters
Tube-to-Tube
Connector (B), for
Flex-Neck Infant
Catheters
Repair Catheter Tubing (C)
Catheter
Connector (D)
FIGURE 1
Tube-to-Tube Connec-
tor (A), for Flex-Neck
Adult, Adolescent, or
Pediatric Catheters
Tapered Tip
Round Ring Barrier
Tapered Tip
FIGURE 3
Catheter Connector D
Threaded Luer
Finger Grip
Raised Shoulder Ridge
Tapered Tip
Proper position of
catheter tubing on
connector
FIGURE 2
Tube-to-Tube Connector
(B), for Flex-Neck Infant
CathetersInsert drawing
Narrower Tapered Tip
Round Ring Barrier
Wider Tapered Tip
FIGURE 4
Catheter tubing with
straight radiopaque
stripe
Raised Shoulder Ridge
Finger Grip