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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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 (b)(6): "when using the flush for the patient, the syringe was found to be broken before the package was opened, and the instrument should be replaced immediately.".
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