Qn #(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported "the catheter is not continuous".The customer returned one opened kit.The snaplock assembly and epidural catheter were removed and were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used as biological material can be seen between the inner coils.Also, the catheter appears to have been cut at the distal end.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter extrusion measures approximately 87.5cm.This indicates at least 1,0cm of the extrusion is missing as the specification for the epidural catheter, indicates the proper extrusion length of an epidural catheter is 88.5-91.5 cm per graphic kz-05400-030 rev.5.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.10.The returned 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-002902) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the likely distal end of the catheter.The flow rate was measured at 8.6ml/min (stopwatch: ref-003150), which is within the specification of 1ml/min minimum.No blockages were found.Specifications per graphic kz-05400-030; rev.5 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110a; rev.1, was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." 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 condition of the sample received.The reported complaint of the catheter not "continuous" could not be confirmed based on the sample received.The customer returned an epidural catheter.Approximately 1.0cm of the returned catheter was missing from the distal end of the catheter.The catheter appears to have been cut.The returned catheter did pass a functional flow test.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, this complaint investigation could not be determined based upon the information provided and the condition of the sample received.No further action is required at this time.
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