BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERSTIX

    MDR report key: 82844 · Received April 10, 1997

    Report

    Report Number
    MW1011121
    Event Type
    Malfunction
    Date Received
    April 10, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 9, 1997
    Manufacturer
    MILES, INC. DIAGNOSTICS DIV.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM NURSES. CANNOT REMOVE THE PROTECTIVE CAP FROM THE NEEDLE (LANCET). PROTECTIVE NEEDLE AND LANCET DETACH AS ONE UNIT. HOSP HAS BEEN USING PRODUCT FOR A LONG TIME AND THIS IS THE FIRST TIME WITH THE PROBLEM. ONE NURSE SAID 50% OF THE UNIT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX LANCETS/LANCETTES FMK MILES, INC. DIAGNOSTICS DIV. * 9616A 11

    Patients

    Seq Age Sex Outcome Treatment
    1 *