Investigation summary: customer returned six 1/2cc, 12.7mm, 29g syringes in an open poly bag from lot # 7156935.Customer states that the stopper was detached from the plunger.All returned syringes were examined and one sample exhibited the stopper separated from the plunger rod.The plunger rod was observed and exhibited a damaged plunger rod tip.A review of the device history record was completed for batch# 7156935.All inspections and challenges were performed per the applicable operations qc specifications.There were two notifications noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (damaged plunger rod tip).Possible root cause for this is a machine jam.
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