(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was torn.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and one epidural catheter.The returned components were received connected together (reference attached files inp20035252).The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed that both appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.Microscopic examination of the catheter revealed the catheter is damaged at approximately 12.1cm (10171599) from the proximal end.The extrusion appears to have a hole.No other damage was observed.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5 rev.7 using the returned catheter and a lab inventory snaplock adaptor with the lab leak tester (ref-002902).The proximal end of the catheter was inserted into the snaplock adaptor until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock adaptor was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter has a hole at 12.1cm from the proximal end, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate unintentional user error caused or contributed to this event.The reported complaint that the catheter was torn was confirmed based on the sample received.During the visual inspection, it was confirmed the returned catheter had a hole at approximately 12.1cm from the proximal end.Also, during the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at the same location discovered during visual inspection.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The torn catheter was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.
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