BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR BD NED UFIN SHRT 0.5ML 31 G 5/16 BD

    MDR report key: 1843476 · Received September 20, 2010

    Report

    Report Number
    MW5017541
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 19, 2010
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT STATES THE SYRINGES ARE DEFECTIVE AND UNABLE TO DRAW UP DOSE. THE PT TESTED 1 SYRINGE WITH A GLASS OF WATER AND SYRINGE DID NOT PULL LIQUID INTO THE BARREL. DOSE, FREQUENCY & ROUTE USED: INJECT 4 TIMES DAILY. THERAPY DATES: (B)(6)2009 TO (B)(6)2010. DIAGNOSIS FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYR BD NED UFIN SHRT 0.5ML 31 G 5/16 BD NONE FMF 0090928

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR