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The account reported that the llad broke several times; according to the facility, the team was using the llad device as normal and the cap broke off, with a delay in medication, the individual reported to be fine, and no medical intervention, serious injury, or follow-up care reported.A photo and a sample were received for investigation; the account provided two photos of the luer lock device and one used luer lock was received for sample review, with no other pack contents returned.The bottom of the luer lock plastic appeared to be melted in and had small pieces of the plastic missing, confirming the reported issue, and no additional defects were noted with the top of the luer lock.This item is received from the supplier/vendor and is not altered before being placed into the kit; medline could not determine the root cause, and the vendor¿s visual inspection, simulated use, anti-cracking test, and dhr review found no defects or abnormalities, with no further action taken and supplier quality monitoring for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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