Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3010631.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
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It was reported that the bd posiflush¿ normal saline syringe flush was missing cap on syringe luer end, still sealed in cellophane wrapper.The following information was provided by the initial reporter: "flush was missing cap on syringe luer end, still sealed in cellophane wrapper." additional info received on (b)(6) 2023.The date of the finding was one day prior to reporting to bd product complaints department, only one syringe was found and reported, it is unknown if other syringes were found and not reported.
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