Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0233724.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.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" syringe had no scale markings on it.The following information was provided by the initial reporter, translated from (b)(6) to english: "on the second day after the operation, the patient had an indwelling intravenous needle on the back of his hand.After the infusion, the tube was sealed with a bdflush.Before the operation, the nurse found that the flush had no mark, and immediately stopped using it and reported it to the head nurse.".
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