This mdr was generated under protocol (b)(4)as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection of the returned samples did not reveal any defects or anomalies with the catheters or the connectors.During the dimensional evaluation, all samples were found to be within specification.The catheter and connector samples were then tested as an assembly (catheter to a detachable hub).One of sixteen samples failed to remain assembled when tested with 5n weight.The inside diameter of the connector from the failed assembly was inspected for defects following the test.No defects or anomalies were found.The separation of the components confirmed the complaint.However, the root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.Udi and report source are unknown.No product information has been provided to date.
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