BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS INC

    MDR report key: 359862 · Received November 8, 2001

    Report

    Report Number
    MW1023322
    Event Type
    Injury
    Date Received
    November 8, 2001
    Date of Event
    October 15, 2001
    Report Date
    November 2, 2001
    Manufacturer
    VITAL SIGNS INC
    Product Code
    FFS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SLIDING CLEAR PLASTIC TUBE GUIDE DESIGNED TO SLIDE DOWN LIGHT WAND AND LODGE INTO ENDOTRACHEAL TUBE CONNECTOR TO KEEP LIGHTED STYLETTE FROM PROTRUDING BEYOND DISTAL END OF ENDO TUBE IS EASILY DISLODGED AND COMES OFF THE LIGHT WAND. THIS TUBE GUIDE DEVICE (APPROX 1CM X 1CM) CAME OFF AND ENTERED PT'S MOUTH AND COULD HAVE POSSIBLY ENTERED THE AIRWAY. USER NOTICED IT AND IT WAS RETRIEVED. A TECHNIQUE OF ENDOTRACHEAL INTUBATION, USER WOULD THINK A NON-DISLODGEABLE GUIDE TO PREVENT ACCIDENTAL ENTRY INTO A PT. AIRWAY OR EYE WOULD BE SAFER. USER HAS USED SUCH DEVICES FOR > 8 YEARS WITH SUCCESS BUT FINDS THIS PARTICULAR DESIGN A POSSIBLE HAZARD TO PTS IN CERTAIN NOT SO UNUSUAL SITUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49920 VITAL SIGNS INC LIGHT WAND OROTRACHAEL STYLET FFS VITAL SIGNS INC 3910 0301C

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention FOR USE WITH LIGHT WAND POWER HANDLE.