Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary : exec summary - samples were received and an investigation was performed.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.A samples returned - customer returned (1) 0.5ml insulin syringe in an open polybag from lot# 1011589.Consumer reported found 1 syringe when removed needle shield, needle hub came off with shield.The returned syringe was examined, and it was observed that the needle hub/shield assembly was detached from the barrel.No damage to the barrel tip was observed.Manufacturing ((b)(4)) will be notified of the observed 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 conformances 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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