BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 31890 · Received March 27, 1996

    Report

    Report Number
    31890
    Event Type
    Injury
    Date Received
    March 27, 1996
    Date of Event
    March 10, 1996
    Report Date
    March 18, 1996
    Manufacturer
    B&B MEDICAL TECHNOLOGIES, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MD ORDERED EXTUBATION. PT WAS VERY COMBATIVE. NURSE TORE OFF ET CUFF AND CLIPPED TAPE HOLDING ET TUBE IN PLACE AND ET HOLDER ATTACHING TUBE TO UPPER LIP. PT WAS EXTUBATED AND PLACED ON MIST. PT CLAMPED TEETH DOWN ON ET HOLDER AND HOLDER CAME OFF TUBE DURING REMOVAL AND WAS NOT NOTED BY NURSE. FOLLOWING DAY, PT WAS IN MORE DISTRESS AND RE-INTUBATED BY ANESTHESIOLOGIST. ET HOLDER WAS FOUND IN THE UPPER AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE PROOF BITE BLOCK ENDOTRACHEAL TUBE HOLDER CBH B&B MEDICAL TECHNOLOGIES, INC. 052595

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention