This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample (needle and catheter) and one (1) photo of the packaging was submitted to the manufacturer for evaluation.Through visual examination of the sample, it was observed that the 20 ga.Open tip echogenic catheter was threaded through the 18 ga.Insulated tuohy needle.However, the returned product does not match the specification drawing.The sample was further evaluated by members of the kits mrb team and compared to a sample from the production floor; it appears that the wire that is attached to the needle was manually removed from the hub.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Based on the investigation, the reported defect was not able to be confirmed to be related to any manufacturing process.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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