(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided material number (b)(4) and lot number (b)(4).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.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.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 wing was broken and "very sharp".The following information was provided by the initial reporter, translated from (b)(6) to english: "flush- the needle wing was broken" "because this problem is repeated many times, the head nurse reported that when the product was opened, no debris was found in it (so it can be ruled out that the product was damaged by violence during transportation), but it was found to be broken during use, and the angle of the break is very sharp".
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