During prep, the hub of the tempo catheter was damaged (cracked) when the catheter was unpacked.There was no patient injury.Another unknown catheter was used to complete the procedure.There were no damages noted to the packaging.The catheter was handled according to the instruction for use (ifu) with no force needed.The products were not returned for analysis.A product history record (phr) review of lot 18038752 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿luer hub- cracked-during prep¿ could not be confirmed.Shipping, storage or handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damage¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
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