BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVOFINE

    MDR report key: 805827 · Received December 28, 2006

    Report

    Report Number
    805827
    Event Type
    Malfunction
    Date Received
    December 28, 2006
    Date of Event
    November 20, 2006
    Report Date
    December 28, 2006
    Manufacturer
    NOVO NORDISK PHARMACEUTICALS INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHEN SCREWING IN NEEDLE TO THE INSULIN PEN, SPRING MECHANISM IN THE NEEDLE CAME LOOSE. THE EXPOSED NEEDLE PRICKED THE NURSE'S FINGER. THIS OCCURRED BEFORE ADMINISTRATION TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE SYRINGE, DISPOSABLE INSULIN FMF NOVO NORDISK PHARMACEUTICALS INC. * 06H24U

    Patients

    Seq Age Sex Outcome Treatment
    1 *