This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample with packaging was returned for evaluation.Sample was subject to a visual evaluation with passing results.The sample was tested as per specification and no leakage was observed.Based on the evaluation results, the reported defect was not confirmed.Retained units were evaluated and passed the internal testing.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.Additionally, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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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