(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not flush.The customer returned one 3 ml luer lock syringe, one snaplock adapter, one epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive can be seen on the outer extrusion of returned catheter and biological material can be seen within the inner coils.After functional testing, microscopic examination revealed the returned catheter does not have opened ports at the distal end as compared to a lab inventory catheter (b)(4).A manual flow test was performed using the returned components.A 20 ml lab inventory syringe was connected to the returned snaplock adapter and other remarks: returned catheter.Using hand pressure, the water was injected.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock adapter with a lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded completely through the catheter until it stopped at the closed tip distal end.Microscopic examination of the distal end of the returned catheter revealed there were no ports holes as compared to a similar lab inventory catheter.Nonconformance, (b)(4), have been initiated to further investigate this complaint issue.The reported complaint of the catheter not flushing was confirmed based on the sample received.The returned epidural catheter was found not to have open ports at the distal end.A device history record review was performed on the epidural catheter with no relevant findings.However, based on the information provided and the results of the investigation, the potential root cause of this complaint issue is manufacturing related.Nonconformance, (b)(4), has been initiated to further investigate this complaint issue.
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