This report has been identified as b.Braun medical internal report number (b)(4).One used sample without packaging was returned from the facility for evaluation.The sample was visually evaluated, and it was noted when put against the drawing the freeflow clamp was upside down.In attempts to replicate the reported defect the sample was attached to an infusion pump and the free flow clamp was inverted which would cause the set not to fit properly or the hook to attach correctly when the set was inserted.Based on the evaluation results, the reported defect of incorrect assembly was confirmed.Incidents of this nature are attributed to operator oversight during the assembly of the product.The freeflow clamp is manually assembled onto the tubing.The operator could have overlooked the position in which they assembled the freeflow clamp.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.An approved project is in place to further address issues of this nature.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.
|