Initial reporter phone #: (b)(6).Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306593 and lot number 2040569.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¿ pre-filled saline syringe was damaged.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, the patient finished infusion.When the responsible nurse sealed the catheter for the patient's intravenous indwelling needle, she found that the joint of the prefilled catheter irrigator was twisted, and the connection between the catheter sealing and the sterile joint of the intravenous indwelling needle was not good, so the catheter could not be sealed.Immediately replace the standard prefilled catheter irrigator to seal the patient's tube.
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