(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was blocked.The customer returned one snaplock assembly.No epidural catheter was returned.The returned snaplock assembly was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.10.A lab inventory epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (ref-(b)(4)) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 9.0ml/min (stopwatch: ref-(b)(4)), which is within the specification of 1ml/min minimum.No blockages were found.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the sample received.The reported complaint of the catheter being blocked could not be confirmed based on the sample received.The epidural catheter was not returned, only the snaplock assembly was returned.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned snaplock passed a functional flow test and met flow rate specifications.However, this complaint investigation could not be determined based upon the information provided and the sample received.No further action is required at this time.
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