Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Two contaminated samples without a package and one photograph of the set label were provided for evaluation.Samples were decontaminated, and visually evaluated, and no defects were observed.Samples were leak tested, and leakage was observed on both samples on the tubing between the pod arterial and pump segment connector.The damage/hole on the tubing caused the air in line and the leakage on the streamline bloodline set.Based on the evaluation results, the reported defects were confirmed.The exact root cause cannot be determined at this time, but user mishandling cannot be ruled out.It is possible that an unknown sharp object during treatment could have caused the leakage.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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