Event 3: this report has been identified as b.Braun medical internal report number (b)(4).Two (2) samples were provided for evaluation.The sets were visually evaluated for any solvent issues with no defect observed.Also, set was functionally evaluated, and leak tested with no leakages observed.Based on the evaluation results, the reported defect was not confirmed.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.In addition, 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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