Device available for evaluation; h3.Device evaluated by manufacturer and h6.Health impact, event problem and evaluation codes: updated.Received twelve (12) unused samples from the same lot number, three (3) from a different lot number not mentioned in the complaint, and one used, locked out needle guard and catheter assembly with sheath component and without blister packaging from an unknown lot number for analysis.The unused samples were evaluated for luer lock and were found to be acceptable with no failures.The used sample was visually examined for any potential related issues such as excessive presence pooled seal lubricant or any manufacturing related damages to the catheter hub.In addition, the used sample was evaluated for luer lock and the used sample was found to be acceptable.The complaint could not be confirmed.A device history record (dhr) review found no reports of abnormalities or discrepancies during the manufacturing of the reported lot number.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.
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