H.6.Investigation summary: samples/ photos: according to the visual analysis of the photos, of the product containing the sample claimed, it was possible to verify that the needle pulled out of the hub.Dhr review: the final assembly lot: 7179921, used in the claimed final product lot: 7173852 was produced from 06/30/2017 to 07/13/2017 in icam # 02.After analyzing this document, a record of failure in the "challenge of the cannula x hub pull off test" on 07/12/2017 at 10:00 was evidenced that may be related to this complaint.This test verifies that 100% of the assembled parts have the needle bonded into the hub after application and curing of the glue.The final assembly lot: 7150926, used in the claimed final product lot: 7173852 was produced from 06/07/2017 to 06/30/2017 at icam # 02.After analyzing this document, no records that could lead to the claimed defect were evidenced.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of "needle pulled out of hub¿ or anything that could lead to this complaint.Investigation conclusion: confirmed: bd was able to confirm the incident in question.Based on the investigations carried out, it can be determined that the root cause of the defect in question is due to a failure in the application and / or curing of the glue inside the hub, followed by a failure of pull off system which verifies that the needle of 100 % of parts are fixed into the hub.
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