It was reported while using bd posiflush¿ normal saline syringe leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, during the process of flushing the infusion port of the patient's infusion port with a 10ml flush, at the part where the infusion connector is connected, the liquid flows out,the nurse immediately replaced the flush with a new one and flushed again.No patient discomfort was caused.
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A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1152448.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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