There were three (3) occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2022-00110.2245270-2022-00111.2245270-2022-00112.Three (3) ams-427 with lot number 2111038d were returned for investigation.The returned set were visually examined to identify any obvious non-conformity relating to the customer claim.We performed a functional test for each sample by using the 10 ml prefilled syringe of sodium chloride to the proximal end of this set and pressurizing the set to help determine the actual location of the suspected leakage.No leaks were observed.Therefore, the issue remains unconfirmed.Corrective action: based on the investigation, this issue could not be confirmed.Therefore, no corrective action will be initiated at this time.Vygon usa will continue to monitor for this issue and escalate as appropriate.
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