(b)(4).The customer returned one 2-l picc for analysis.Signs of use were observed on the catheter body and inside the extension lines.The catheter body was observed to be intentionally severed at the distal tip.Visual inspection of the catheter revealed no obvious defects or anomalies.The length of the catheter body from the juncture hub to the severed end measured 14 1/2" which is not within the specifications of 19 1/2" - 20" per product drawing.This indicates that at least 5" of the catheter were severed and not returned for analysis.Functional inspection of the catheter was performed per the instructions for use (ifu) provided with the kit which states, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." the distal and proximal lumens of the catheter were flushed using a lab inventory 10ml syringe.The extension lines flushed normally.No leaks or blockages were observed.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit warns the user, "ensure catheter patency prior to use, including priorto 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 revealed no obvious defects or anomalies.The returned catheter met all relevant functional requirements, with no blockages observed.A device history record review based on sales history 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.
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