Investigation summary:customer returned (1) 1/2cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 7296788.Customer states that the shield was missing, the needle was bent, the shield was broken, and the needle was found in the bottom of the bag.The syringe was examined and exhibited a broken shield and a bent cannula.No missing shield or separated cannula was observed on the returned sample.A review of the device history record was completed for batch# 7296788.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200724502] noted for no shield.There were five (5) notifications [200724475, 200724479, 200724476, 200724452, 200721796] 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 (bent cannula, broken shield).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (needle separates, missing shield).Investigation conclusion: possible root cause: likely a jaw jam of form fill & seal which bent the cannula and then made it to packaging.Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: yes.
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