BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD

    MDR report key: 928441 · Received October 12, 2007

    Report

    Report Number
    MW5004083
    Event Type
    Injury
    Date Received
    October 12, 2007
    Date of Event
    October 11, 2007
    Report Date
    October 12, 2007
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BOXES OF BD ULTRA-FINE 3 SHORT PEN NEEDLES ARE DEFECTIVE. PROBLEM WITH HALF OF NEEDLES IN TWO BOXES WITH TWO DIFFERENT LOT NUMBERS: #7003192 AND #7092615. PROBLEM: WHEN PRIMING THE NOVOLOG PEN WITH TWO UNITS OF INSULIN HALF THE TIME ONLY DROPLETS OF INSULIN COME OUT INSTEAD OF A STEAM OF INSULIN INDICATING THAT THE NEEDLE IS DEFECTIVE. VERY DANGEROUS! PATIENT WILL GET THE WRONG DOSE OF INSULIN IF NOT OBSERVANT ENOUGH TO CHANGE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD BD ULTRA-FINE 3 SHORT PEN NEEDLES FMI BECTON, DICKINSON AND CO. 7092615
    2 BD BD ULTRA-FINE 3 SHORT PEN NEEDLES FMI BECTON, DICKSON AND CO. 7003192

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening