It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: at 09:00 on (b)(6) 2023, the patient underwent fluid replacement therapy in the morning.When using 5ml bd, it was found that the bolus could not be continued when the bolus reached 1ml, so it was replaced immediately without affecting the patient.
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Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306594 and lot number 2026232.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.
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