BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILET

    MDR report key: 408615 · Received July 25, 2002

    Report

    Report Number
    1810909-2002-00177
    Event Type
    Malfunction
    Date Received
    July 25, 2002
    Date of Event
    May 6, 2002
    Report Date
    July 24, 2002
    Manufacturer
    BAYER CORP.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT REPORTED A STAFF NURSE AT HOSP, OPENED A BOX OF LANCETS, PICKED OUT A LANCET AND PLACED IT ON THE GLUCOLET LANCING DEVICE. THE PROTECTIVE CAP WAS NOT ON THE LANCET AND THE NURSE PUNCTURED A FINGER WITH THE LANCET NEEDLE. IT WAS UNK IF THE CAP FROM THE LANCET WAS IN THE BOTTOM OF THE BOX OR IF THIS BOX WAS JUST RECENTLY OPENED. FOLLOW-UP IS BEING ATTEMPTED ALONG WITH A REVIEW OF MANUFACTURING RECORDS TO DETERMINE THE SCOPE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINILET BLOOD LETTING DEVICE FMK BAYER CORP. 5966 J113714

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN