BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEED UF SHRT 8MM 90S - 31Q5/16

    MDR report key: 2910221 · Received January 7, 2013

    Report

    Report Number
    MW5028505
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    BD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PEN NEEDLE BROKE OFF INTERNALLY. DOSE, FREQUENCY, ROUTE USED: 5 X DAILY SUB Q. DIAGNOSIS FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6760 BD PEN NEED UF SHRT 8MM 90S - 31Q5/16 NONE FMI BD 2153023

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR