Pr (b)(4) follow up for device evaluation.It was reported the syringe broke and cut the dr's hand.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed, and the syringe barrel is damaged at the flange.No other defects or imperfections were observed.This defect could occur if there was a jam during the assembly process.A device history record review was completed for provided material number 302832, lot 3352922.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the assembly process was performed.The alignments of rails and conveyors were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
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