A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One sample was received at the manufacturing site for the investigation.The sample was evaluated, and the reported issue was confirmed; plastic fragments were observed inside the barrel.The plastic fragments inhibit actuation of the plunger; when fully actuated the point of the rubber tip is at the 0 ml graduation mark with the distal side of the rubber tip reaching the 1.8ml mark.The plastic fragments found in the barrel are consistent with a crushed part and are most likely the remnants of a crushed barrel that occurred during the molding process.The fragments were likely inserted into the barrel during part transfer.During the assembly process (ram), a sensor detecting the position of the plunger should have rejected the part as the plunger would not be fully seated; however, it¿s possible that the plunger was actuated enough that the sensor detected the plunger and did not reject the part.Statistical sampling is used to detect this type of issue.The manufacturing and complaint review did not find any similar failure modes.Therefore, it is likely that the sample represents a one-time event.Based on all available information, a corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
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