Device evaluation: one used and decontaminated epidural catheter assembled to an epidural catheter connector and a flat filter were returned for evaluation.Visual inspection of the flat filter and connector, found them to be in good physical condition.Visual inspection of the returned catheter revealed that the tip appeared to be smooth and rounded.All catheter eyes were present and were properly formed.A dried substance was noted throughout the inside of the catheter; preventing further visual inspection.Attempts were made to remove the catheter from the connector to allow further dimensional testing, but were unsuccessful.Functional testing included testing for proper fit using the corresponding epidural needle for the returned kit.The distal tip of the catheter passed through the hub of the needle until it passed through the bevel tip; a slight resistance was noted.The results were found to be acceptable.The presence of the dried substance may support the customer's claim for the occurrence of an intravascular penetration.However, the returned catheter was found to be within specification and was fully formed with a smooth, rounded tip.Conclusively, the investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
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