Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1140605.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.There are quality controls currently in place to detect this type of defect during the production process.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 plunger was found to be damaged during use.The following information was provided by the initial reporter, translated from (b)(6): "when sealing the tube of the intravenous indwelling needle for the patient, it was found that the plunger of the flush was damaged, which was easy to cut the skin and exposed the skin to the operator.".
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