Investigation summary: exec summary: samples were received and an investigation was performed.A review of the complaint lot history check was performed and this is the 7th related complaint for needle hub separates on this lot #.No non-conformance's were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Samples returned: customer returned (1) 3/10cc, 8mm, 30g syringe in an open poly bag from lot # 0286309.Customer states that the hub separation is occurring before use.The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel.Manufacturing ((b)(4)) will be notified of this issue.Capa/sa: capa (b)(4) has been opened to address this issue.Dhr review: a lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
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