This report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples with packaging were returned for evaluation.The returned samples were visually evaluated per specification with passing results.No hole or imperfections were observed.During the functional testing, no occlusion nor leakage was observed.Based on the evaluation results, the reported defect was not confirmed.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.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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