BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYR MF 1CC 1S 28G

    MDR report key: 1584352 · Received January 20, 2010

    Report

    Report Number
    MW5014443
    Event Type
    Malfunction
    Date Received
    January 20, 2010
    Date of Event
    November 20, 2009
    Report Date
    December 18, 2009
    Manufacturer
    BDK
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED AND STATED HE HAD TO THROW SEVERAL OF THEM AWAY BECAUSE THEY HAD "SPURS" ON THE NEEDLE TIPS, AND HE WAS UNABLE TO INJECT HIMSELF. DOSE, FREQUENCY: USE 4 PER DAY AS DIRECTED. THERAPY DATES: (B) (6) 2009. DIAGNOSIS FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SYR MF 1CC 1S 28G NONE FMF BDK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NOVOLIN 70/30 VIAL| LANTUS VIAL