(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 58929.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.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.
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It was reported that the syringe 5ml saline fill experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: when preparing to flush the catheter with the indwelling needle for the patient, device operator opened the flushs outer package and found that the syringe of the syringe was skewed, immediately replaced another one, and successfully completed the flushing for the patient, connect intravenous infusion.
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