Event 5: this report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Although no sample was provided, the complaint report confirms that this is similar to other complaints of this nature.Incidents of this nature are attributed to operator oversight during the assembly process.Although our training procedures ensure that all our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.Retained units were evaluated and passed the internal testing.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.Additionally, 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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