This report has been identified as b.Braun medical internal report number (b)(4).Two used sample without packaging were returned from the facility for evaluation.The visual evaluation was performed on the two samples returned and it was noted that one out of the two samples returned was attached to the infusion pump when compared to the drawing it was observed that in one of the samples the entire pump segment was inverted and disassembled to the finished good.Also, it was noted during visual evaluation that one out of the two samples was missing a roller clamp from the set.Based on the results of the investigation the reported defect of the assembly incorrect was 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 an approved project was initiated to enhance the assembly process in to order to reduce occurrences of inverted space pumps during the manufacturing of this product.All applicable personnel involved in the assembly and inspection of this product will be trained 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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