BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE NEEDLE GUARD

    MDR report key: 432089 · Received December 4, 2002

    Report

    Report Number
    MW1026929
    Event Type
    Malfunction
    Date Received
    December 4, 2002
    Date of Event
    November 27, 2002
    Report Date
    December 4, 2002
    Manufacturer
    SAFETY SYRINGES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ULTRASAFE NEEDLE GUARD USED ON LOVENOX SYRINGE. VERY DIFFICULT TO ACTIVATE NEEDLE GUARD WITH ONE HAND, SO NURSES ROUTINELY USE TWO HANDS. NURSE STUCK THEIR FINGER WITH NEEDLE IN PROCESS OF ACTIVATING GUARD WITH TWO HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASAFE NEEDLE GUARD NEEDLE GUARD FMI SAFETY SYRINGES, INC. B50 AVENTIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other