Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 1152091.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.
|
It was reported that the bd posiflush¿ syringe the wall of the syringe was leaking.The following information was provided by the initial reporter, translated from chinese: ¿the patient was admitted to the hospital on (b)(6) 2022 due to "nausea and vomiting for 2 days", and the admission diagnosis was: chronic gastritis.After admission, intravenous indwelling needle should be used for infusion, and a flush should be used for flushing.(b)(6) 2022 after the end of the intravenous infusion, when theflush was used to flush the tube, it was found that the wall of the flush was leaking and could not be used any more, so the new one was immediately replaced and the completion was continued.Operate.No adverse effects were caused to patients.¿.
|