Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 1202752.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.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¿ normal saline syringe leaked after the infusion and a crack was found in the barrel.The following information was provided by the initial reporter, translated from chinese: "when the patient's indwelling needle was sealed after the patient's infusion, the nurse used the flush according to the operating procedure, and found that the wall of the syringe was leaking, and immediately stopped the operation.It was found that the syringe of the flush had an arc-shaped crack of about 5cm long, and the flush was replaced.".
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