A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2034412.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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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: when routine infusion therapy was performed for the patient according to the doctor's advice, the prefilled catheter could not be advanced normally, and it still could not be advanced after adjusting the connector, but it could be used normally after replacing the irrigator.
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