Date of event: unknown.The date received by manufacturer has been used.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2103502, medical device expiration date: 2026-02-28, device manufacture date: 2021-03-23.Medical device lot #: 2104120, medical device expiration date: 2026-03-31, device manufacture date: 2021-04-26.Investigation summary: samples and photos received for investigation.Upon observation, all syringes received present defects in the luer lock and tip pf the syringe.One syringe has the luer lock detached.Five syringes present the tip completely detached, and two devices have the thread damaged.The eight syringes sent by customer came without lot number identification, so we cannot associate to each device one of the two lot numbers given.A device history review was performed for reported lot 2103502 and 2104120, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Possible root cause can be related with the damaged pins in the mold where the parts were manufactured.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.No corrective action is required at this time.
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It was reported that syringe non sterile 50ml ll was damaged.This occurred on 7200 occasions.The following information was provided by the initial reporter: according to our analysis, it is an injection molding defect on the luer cone.To us, it looks like the cone is injected twice.
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