Dhr for lot number 8008626 was reviewed and no qns or other events were related to the complaint stated by the customer.Material (b)(4) with lot number 8008626 was manufactured on january, 2018.According to sampling plan applied, this lot was accepted without any defect or deviation.During this lot, 125 samples were inspected visually during the final audit without found any defect the inspection is performed by qa tech on final inspection of the kit.The epidural catheter it is received from external supplier during the process only the outside diameter is verified 100% tread assist is installed into epidural catheter, at raw material receipt a random sampling is taken to perform visual inspection by missing marks on the tip formed end, on reported batch the following batches of epidural catheter 115370273mex were used 73f1700294, 73d1700462, 73d1700463, & 73f1700086 all of these lots were received without found any defect at incoming inspection.Manufacturing process was reviewed and no potential failure modes were found.No sample or photos were provided to perform sample evaluation.All relevant information during the dhr review shown that meet all established manufacturing criteria.We could not determine the root cause and cannot confirm the issue stated by the customer due that no samples/photos were sent for evaluation.
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