BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE

    MDR report key: 5986623 · Received September 26, 2016

    Report

    Report Number
    MW5065089
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A BD 10ML SYRINGE WAS USED TO PREPARE A DOSE OF METHYLENE BLUE FOR A PT. FLUID WAS FOUND TO LEAK BEYOND THE SECOND RIB OF THE STOPPER INTO THE PORTION OF THE BARREL EXPOSED TO OUTSIDE AIR. THE BD REFERENCE NUMBER IS (B)(4) AND THE BARCODE NUMBER IS (B)(4). THE LOT NUMBER OF THE SYRINGE IS 6173682.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630509 BD 10ML SYRINGE BD 10ML SYRINGE FMF BD 6173682

    Patients

    Seq Age Sex Outcome Treatment
    1