BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYR NED UFIN SHRT 0.3ML 31G 5/16

    MDR report key: 2171315 · Received July 15, 2011

    Report

    Report Number
    MW5021406
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATES SOME OF THE NEEDLES WERE BENT ON THE SYRINGE. DOSE: USE 2 DAILY FOR DIABETES. THERAPY DATES: (B)(6) 2010 TO PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SYR NED UFIN SHRT 0.3ML 31G 5/16 NEEDLE FMI 1024629

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR