(b)(4).A device history record review was performed on the kit, lor syringe, and medicine cup with no relevant findings.The customer reported that "when flushing the lor syringe before use, some black materials came out from the syringe." the customer returned one glass lor syringe and one medicine cup.The returned samples were visually examined with and without magnification.Visual examination of the returned medicine cup revealed that the medicine cup was wrapped and taped with parafilm.There were black particulates on the surface of the medicine cup.Presence of what appeared to be a shiny substance was found at the bottom of the medicine cup.The particulates varied in size.Visual examination of the returned syringe revealed that there is residue on the barrel of the syringe.Smaller black particulates were present on barrel of syringe.The plunger would stick and not slide completely.Microscopic examination of inside the barrel of the lor syringe from the top to the tip reveals a black discoloration at the bottom of the barrel of the syringe as compared to a new lab inventory syringe which does not appear to have a black discoloration.It cannot be determined if the discoloration is on the inside surface of the barrel at the tip or the outside where the tip is adhered to the glass surface.No other defects or anomalies were observed.Nonconformance, (b)(4), have been initiated to further investigate this complaint issue.The reported complaint of black particulates on the medicine cup after flushing the lor syringe was confirmed based on the sample received.Visual examination of the returned sample revealed particulates on the surface of the returned medicine cup.Visual examination of the returned syringe revealed that there is residue on the plunger.However, microscopic examination of the inside the barrel of the lor syringe from the top to the tip revealed a black discoloration at the tip as compared to a new lab inventory syringe.A device history record review was performed on the kit, lor syringe, and medicine cup with no evidence to indicate a manufacturing related issue.The lor syringe is a purchased part.Therefore, the potential root cause of this issue is supplier related.A nonconformance, (b)(4), has been initiated to further investigate this issue.
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