Investigation summary: to aid in the investigation, three photos were provided for evaluation by our quality team.The photos show a syringe with the tip cap removed.The syringe barrel luer has discoloration as well as inside the bottom of the tip cap.No other defects or imperfections were observed.A device history record review was completed for provided material number 306547, lot number 2154734.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.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.
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