Investigation summary: one (1) 1/2cc, 8mm, 30g syringe was returned in an open poly bag from lot # 6179912.Customer states that there was a hardened plastic inside the syringe barrel.The returned syringe was examined and exhibited a loose, hard piece of material inside the barrel.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis suggests that this material has components similar to those of polypropylene.As per manufacturing, a review of the device history record was completed for batch# 6179912.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure mode.Investigation conclusion: possible root cause: the grinder at the mold press can discharge barrel runner pieces which are kicked out of the grinder and the air transfer system for the parts pulls the regrind pieces into the tote with the molded barrels.Static charge can cause the runner pieces to adhere to the tote or molded components.Totes of molded components are transferred to the assembly operations, which then are emptied into the vibratory bin.This can dislodge the regrind piece, which can potentially find its way into the barrel fluid path.
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