(b)(4).The customer returned one epidural catheter, one snaplock adapter with clip, and one flat filter.A visual exam was performed on the filter and it was observed that the filter had tooling marks in the female luer.No other defects were observed.No issues were found with the snaplock adapter; however, the catheter appeared to be used as adhesive residue was present on the catheter body exterior.A small cut in the extrusion could be seen near offset coils approx 40cm from the distal end.No other defects were observed.Functional testing was performed and a leak could be seen immediately from the location of the offset coils in the catheter.No other leaks were detected.The test was repeated with the returned snaplock adapter and a lab inventory epidural catheter.No leaks were detected indicating that there are no functional problems with the returned snaplock adapter.A manual leak test was performed with the returned flat filter and no leaks were detected.A dhr review was performed on the epidural catheter and snaplock adapter with no relevant findings.The reported complaint of a leak from the connector was not confirmed based on the returned sample.The components were submitted to leak testing and neither the snaplock adapter, nor the flat filter other remarks: returned were found to leak.The returned catheter was found to leak as a result of a small cut in the extrusion located near offset coils.A dhr review was performed on the epidural catheter and snaplock adapter with no evidence to suggest a manufacturing related cause.Therefore, based on the damage observed and the time of discovery, it was determined that operational context caused or contributed to this event.
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