Investigation summary: it was reported that syringes found with black and white dots and are damaged or broken.To aid in the investigation, ten samples and nine photos were received for evaluation by our quality team.The samples came bulk packaged.A visual inspection was performed and damaged syringe barrels, embedded degraded resin and rubmarks were observed.Rubmarks are imperfections and considered acceptable.The photos provided show some of the samples received.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.For the damaged parts defect, it is likely that a jam occurred during the assembly process resulting in the damage to the syringes.As the lot provided is 'unknown,' a device history record review could not be completed.Verification of the assembly equipment was performed.Alignment of rails and conveyors were acceptable.Flow of products was good.Frequency of inspections were increased to mitigate the embedded degraded resin escapes.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
|