BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLOR CUFF TOURNIQUET CUFF

    MDR report key: 41773 · Received October 8, 1996

    Report

    Report Number
    MW1010029
    Event Type
    Malfunction
    Date Received
    October 8, 1996
    Date of Event
    May 17, 1996
    Report Date
    May 17, 1996
    Manufacturer
    INSTRUMED, INC.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CO REP GAVE RPTR THE NUMBERS 90-5181, 90-5241, 90-5341, 90-441 AS NUMBERS FOR ORDERING STERILE DISPOSABLE CUFFS. PRODUCT USED FROM 11/7/95 TILL 5/17/96 AS IF IT WAS STERILY PACKAGED. RPTR WAS TOLD TODAY THESE ARE NOT STERILE. PACKAGE NOT MARKED NONSTERILE. NORMAL USE FOR THIS PRODUCT IS IN A NONSTERILE SETTING. OCCASIONALLY RPTR USED IT ON A STERILE FIELD. RPTR UNABLE TO TRACK WHEN THIS PRODUCT WAS USED IN A STERILE SETTING OR IF IT WAS THIS PRODUCT OR OTHER CO'S PRODUCT. IT WAS A STAFF ERROR USING THIS PRODUCT IN A STERILE SETTING IF NOT MARKED STERILE. IT WAS CO REP'S ERROR IN GIVING WRONG PRODUCT NUMBER. PACKAGING OF PRODUCT IS THE SAME FOR STERILE AND UNSTERILE CUFFS. RPTR FEELS THIS IS POOR AND CONFUSING AND PACKAGES NEED TO BE STAMPED "UNSTERILE" WHEN PACKAGED IN "STERIBLE" PEEL OPEN PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLOR CUFF TOURNIQUET CUFF TOURNIQUET CUFF GAX INSTRUMED, INC. * 272934

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other