B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: one hundred fifty-eight samples were provided to our quality team for investigation.Through visual inspection, it was observed that syringes have an ink ring down by the flange outside the print area.The ink ring does not affect form, fit, or function of syringes.Additionally, four syringes have one ink dot which are acceptable per quality specification.Furthermore, two syringes have one large ink dot, two syringes have a cross-threaded needle attached to the syringe, one syringe has an insecure stopper on the end of the plunger, one syringe is missing print from the zero line to the 1/2ml area of the barrel, and one syringe has a broken needle hub.The conditions observed are non-conforming per product specification.Potential root cause for the ink ring, ink dots and missing print conditions are associated with the marking process.Potential root cause for the cross-thread needle, insecure stopper and broken needle hub defects are associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3: see h10.
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