Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Although no samples were returned, one photo was provided for further evaluation.The photo was visually evaluated per specification and cracks were noted at the center of the cap.Several attempts were made to replicate the defect with house retain samples.We were only able to replicate the defect when we intentionally overtightened the cap while screwing it with the syringe.The defect of caps broken has not been confirmed.The house retains were visually evaluated per specification and no defects were noted.The luers of the caps were verified to be within specification.The caps were then screwed on to b braun omnifix syringe with passing results.No cracking or leakage was noted.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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