Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306595 and lot number 2034419.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.
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It was reported that 30 bd posiflush¿ normal saline syringe the tips were damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: today, it received a product complaint from the operating room of the hospital, product number 306595, batch number: 2034419, 30 pieces (1 box): the outer packaging of the product is intact, and the product head is crooked and has no cap.
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