Event 14: this report has been identified as b.Braun medical internal report number (b)(4).Eighteen samples 10 used without packaging and 8 unused in unopened packaging were returned by the facility for evaluation.The 18 samples provided were all visually evaluated and it was noted all 18 samples had an inverted space pump.The reported defect is confirmed.Incidents of this nature are attributed to operator oversight during the assembly of the product.Although our training procedures ensure that all 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.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.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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