It was reported while using bd posiflush¿ normal saline syringe the stopper was deformed.There was no report of patient impact.The following information was provided by the initial reporter: (b)(6) 2022, when the nurse connected the needle bolus with the catheter irrigator, there was fluid leakage from the stopper.Preliminarily consider the product quality problem, immediately replace a catheter flusher, and notify the supplier to return the product of this batch number.
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A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1271179.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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