A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.During the manufacturing of the syringe assemblies, 2,048 syringes were visually inspected and 1 ,029 syringes were physically tested with zero issue were recorded relating to this customer report.The molded syringe barrel inspection reports were reviewed with zero issue.No non-conforming product identified relating to this customer report.The molding maintenance work orders and mold repair cavitation were reviewed.There were no unusual repairs identified.The returned samples contained 4 syringes.A purple cap was attached to the luer slip of the syringe barrel on one of the four syringe samples.Plastic particulate matter was identified on the inside diameter of the syringe barrel, on the face and side of the rubber tip.Damage to the stop ring feature of the syringe barrel was identified.The condition of particulate in the fluid pathway is confirmed on four of the syringe samples.In accordance with quality information system (qis) ¿major a, aql=.065, particulates and extraneous matter in fluid pathway.¿ per aql inspector slide rule, ansi/asq 21.4-2008, 4 defects at an aql of.065 are not within the acceptable quality limits for a lot size of 100,125 pieces.Sample size of 800 with acc.1 / rej 2.A definitive root cause was not determined, but the potential root cause identified a couple of contributing factors to the reported condition: 1.Mold tool age and wear 2.Partial blocking of the cooling system for a specific cavity.These issues may have caused parts to intermittently stick in the cavity not being detected during the mold cycle.This could occur between inspection intervals because of low or random frequency.During production, the processing equipment is checked regularly to verify that the systems are functioning properly.A lot cannot be released unless it passes specification requirements.Corrective action: a corrective and preventative action (capa) has been opened to focus on this complaint and similar processes, to implement horizontal deployment.If information is provided in the future, a supplemental report will be issued.
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