(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306575 and lot number 0230777.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.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Root cause description: based on the investigation results, an exact cause for this incident could not be identified.Rationale: further action has not been determined necessary at this time.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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It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% had difficult plunger movement.The following information was provided by the initial reporter: "unable to instill ns fully from syringe.Significant resistance, removed from patient catheter, and tested, remained resistant.Stopped at ~ 3ml mark of 10 ml prefilled ns syringe.".
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