Qn # (b)(4).The customer returned one, opened picc kit including: two straight guide wires within their advancers (one 45 cm and one 80 cm), a 21ga introducer needle, a 10ml syringe, a single-lumen picc catheter, and the product lidstock for analysis.No obvious signs of use were observed on the catheter body.Visual inspection of the picc catheter revealed no obvious defects or anomalies.The length of the catheter body from the juncture hub to the distal tip measured 19 13/16" which is within the specifications of 19 1/2" - 20" per catheter product drawing.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal lumen was flushed using the returned 10ml syringe.The extension line and catheter body flushed as intended.No leaks or blockages were observed.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit warns the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter.Minimize catheter manipulation throughout procedure to maintain proper catheter tip position." the customer report of a blocked catheter could not be confirmed through complaint investigation of the returned sample.Visual inspection of the picc catheter revealed no obvious defects or anomalies.The returned catheter met all relevant dimensional/functional requirements, and was able to flush as expected with no blockages observed.A device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
|