Device evaluation: one spinal needle, catheter connector, epifuse epidural luer, luer slip, and a flat filter were returned from the customer for investigation.The returned components were accompanied by a certificate of safe handling.From the complaint description it was determined that the component which leaked and did not locked was the catheter connector component.The device and affected components were tested against the requirements and no issues were found.The returned items passed inspection.No leakage was observed.Based on the investigation, the complaint allegation was not confirmed.No fault was found with the devices or its components.
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