BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO FINE AUTO COVER 30G 8MM

    MDR report key: 820317 · Received February 13, 2007

    Report

    Report Number
    820317
    Event Type
    Malfunction
    Date Received
    February 13, 2007
    Date of Event
    January 21, 2007
    Report Date
    February 13, 2007
    Manufacturer
    NOVO NORDISK INC
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE FOR THE INSULIN PEN BENT WHILE GIVING A PATIENT AN INJECTION. WHEN NEEDLE WAS WITHDRAWN, THE SAFETY FEATURE DID NOT GO ON. THE NEEDLE WAS BENT INSIDE DEVICE AND THE PATIENT WAS LEFT WITH A VERY LITTLE 1 INCH SCRATCH ON THEIR RIGHT UPPER ARM. THE CONCERN IS NOT WITH THE SCRATCH BUT INSTEAD, NOT KNOWING WHETHER THE INSULIN ACTUALLY GOT INTO THE PATIENT OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVO FINE AUTO COVER 30G 8MM SYRINGE, SAFETY MEG NOVO NORDISK INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *