Qn# (b)(4).The customer returned a connector assembly to a hemodialysis catheter.No other components (including the catheter body) were returned.Visual examination of the catheter body could not be performed as it was not returned for investigation.The connector piece was visually examined and no issues were identified.The right cannula tip had dimensions of 0.72" (width) and.134 (length) which were within specifications.The left cannula tip had dimensions of 0.73" (width) and.135 (length) which were within specifications.The returned connector assembly was able to connect to a lab inventory hemodialysis catheter body with no issues.A device history record review was performed and no relevant manufacturing issues were identified.Instruction booklet directs the clinician to insert the hub connection assembly cannula into the lumens of the catheter.The ifu cautions: ensure the hub connection assembly cannula is fully seated into the catheter and that no cannula is visible.Failure to do so could compromise compression of the catheter onto connector and catheter separation could occur.The report that the connector piece could not connect to the catheter could not be confirmed based on the sample received.No issues were found during visual examination and the connector piece was able to connect to a lab inventory hemodialysis catheter body.In addition, a device history record review was performed with no relevant findings identified.Therefore, the probable cause of this complaint could not be determined based upon the information provided and without the catheter being returned.Teleflex will continue to monitor and trend for reports of this nature.
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