Medical device expiration date: unknown.Initial reporter phone#: (b)(6).Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.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¿ syringe had sharp molding defects on the edge that cut the nurse's finger.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse unpacked the flush, she found that the edge of the syringe was damaged and there were defects, which cut the nurse's finger.".
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