Investigation summary: it was reported there is foreign matter, scale marking defects and damage.To aid in the investigation, ten samples in a bulk plastic bag and six photos were provided for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.Four samples have embedded degraded resin and two samples have the plunger rod damaged.Three samples have rub marks imperfections and one has a scale printing imperfection.Imperfections are considered acceptable.The six photos show some of the samples received.A device history record review was completed for provided material number 301033, lot number 1026746.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To mitigate the escapes of this symptom, inspection frequencies were increased.To date, there have been no other similar events reported for this lot.Investigation conclusion: 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.Root cause description: probable root cause.Molding process.The embedded degraded resin occurs at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the system of the tooling mold and press.The degraded resin can break loose and be molded into components.The inspection frequency was increased to mitigate the escape of this symptom.Rationale: capa not required at this time.
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