Investigation: based on the analysis of the sample returned from the client, it is not possible to confirm the reported defect, since no characteristics were detected in any of the analyzed sample components that could cause an activation failure.In addition, there are no records in production histories, non-conformities or corrective maintenance that could clearly lead to this complaint for the lot involved in this complaint.Based on the investigations of this complaint, it was not possible to assign a root cause for the incident to date since the complaint was not confirmed.Samples/ photos: it was received one sample opened and unused of insyte autoguard 22g x 1.00, catalog number 38182314 from lot: 7122627.After visual analysis of the sample, were no detected damage or characteristics in any of the components (barrel, grip, bottom) of the product that could lead to a failure to activate the safety device.Dhr review: the assembly lot: 7116584, used in the claimed final product lot: 7122627 of insyte autoguard 22g x 1.00 was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced record of failure of activation of the part during the analysis of these batches.Qn/ ncmr review: there are no qn records of this defect for batches related in this complaint.Unplanned maintenance: the corrective maintenance history in the manufacturing period of the assembly lot involved in this complaint was evaluated and no records were recorded that could clearly indicate a failure of the activation of the part.Not confirmed: bd was unable to confirm the incident in question.
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