BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NED UF MINI 5MM, 31G 3/16

    MDR report key: 2033293 · Received March 24, 2011

    Report

    Report Number
    MW5019965
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 14, 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

    WHEN PT TAKES OFF THE CAP THE NEEDLES ARE BENT. YESTERDAY, PT THOUGHT NEEDLE WAS LEFT IN SKIN AFTER INJECTION AND WENT TO ER BUT NO NEEDLE WAS FOUND. PT FOUND OTHER NEEDLES IN BOX WHERE NEEDLE IS BENT. PT REC'D 3 BOXES, THIS IS HAPPENING WITH 1 OF THE BOX TOWARD THE END OF IT. PT HAS BEEN USING THESE FOR YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PEN NED UF MINI 5MM, 31G 3/16 PEN NEEDLE FMI 0189248

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR