BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMES FINGERSTIX LANCET

    MDR report key: 15062 · Received August 4, 1994

    Report

    Report Number
    MW1003029
    Event Type
    Malfunction
    Date Received
    August 4, 1994
    Manufacturer
    MILES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ICU/CCU NURSE REPORTED THAT ON A FEW OCCASIONS THE NURSES HAD PROBLEMS WITH THE LANCETS. WHEN ATTEMPTING TO REMOVE THE PLASTIC PROTECTIVE PIECE FROM THE "SHARP," THE "SHARP" CAME OUT WITH IT. THE PLASTIC PIECE SEEMS TO BE FUSED TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMES FINGERSTIX LANCET LANCET FMK MILES, INC. 9302 B21

    Patients

    Seq Age Sex Outcome Treatment
    1 *