(b)(4).The customer reported the flat filter was leaking during use.The customer returned one snaplock adapter with clip, one flat filter, and one epidural catheter.The components were received connected.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive material can be seen on the outer extrusion and biological material can be seen between the inner coils.No other defects or anomalies were observed.A manual flow test was performed on the returned filter by connecting a laboratory inventory syringe to the luer-slip end of the returned filter and manually injecting water.Water was observed exiting the luer-lock end of the filter.Then a closed snaplock adapter was connected to the luer-lock end while the laboratory inventory syringe was still connected to the luer-slip end.Water was once again injected into the filter.No leak was detected coming from the returned filter.A device history record review was performed on the flat filter with no relevant findings.A corrective action is not required at this time as the complaint could not be confirmed.No functional issues were found with the returned filter.The reported complaint of the filter leaking could not be confirmed based on the sample received.A device history record review was performed on the flat filter with no evidence to suggest a manufacturing related cause.The returned filter passed a manual leak test.There were no functional issues found with the returned filter.Teleflex will continue to monitor and trend related events.
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