It was reported that the bd posiflush¿ syringe plunger was found damaged when opening the packaging.The following information was provided by the initial reporter, translated from chinese: "when the patient is given the flushing and sealing tube treatment at the end of the treatment, after opening the outer package of the instrument, the bottom part of the syringe is found to be defective, and the instrument should be replaced immediately.".
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 0170202.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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