Investigation summary: six photos and eight samples were received by our quality team for evaluation.From the photos, the team observed a damaged barrel and illegible scale marking, the team was not able to determine the functional failure on the plunger movement difficult.Six samples were received for plunger movement difficult, and two samples were returned for damaged barrel and scale marking issue.The samples returned for the damaged barrel issue were observed with damage at the barrel body which caused the printing rub off.The samples returned for the plunger movement difficult were subjected to the plunger breakout and sustaining force test and were within specification.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.As the samples passed the plunger breakout and sustaining force testing, a root cause was not able to be determined.For the barrel damage, the team investigated different sections of the syringe machine and matched a potential area which could lead to the reported defect.The syringe barrel damage could have occurred at the assembly machine.At the syringe assembly process, there is an auto-reject station where the rejected syringe will be removed.The probable root cause of barrel damaged could be due to the defect sample not being kicked-out at the auto-reject station effectively.The syringe tip could have dislodged from the dial pocket and hit against the guide skirt; however, the barrel was stuck at the assembly dial.The damage on the barrel caused the printing rub off.A new air-jet will be fabricated to improve the auto-reject station to increase air flow and improve proper kick-out of the rejected parts.Communication with the production technicians to raise awareness on the reported defects.This incident has been added to our database of reported incidents.
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