Investigation summary: as no physical sample, part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.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 11 unspecified bd emerald¿ syringes leaked while administering medication, and 1 needle broke.The following information was provided by the initial reporter: "it was reported via post market survey that clinicians encountered any leakage during medication administration, resulting in an inaccurate dose being given (11) and broken needle (1)."additional information related to medication(s) that leaked while using the bd emerald¿ syringe - iomeron 400, lasix, saline solution, glucose-based solution." "leakage of fluid from the connector of the needle during the injection.".
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