This report has been identified as b.Braun medical internal report number (b)(4).One (1) used sample without packaging was provided for evaluation.A visual evaluation was performed and under magnification, the material was found to be embedded in the molding of the drip chamber.The supplier was contacted and based on the suppliers evaluation the "foreign material" was confirmed to be embedded degraded pvc( material of the soft chamber) and would not would not affect the functionality of the part and would not have contribute to contamination of drip chamber.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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