BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 2578410 · Received May 10, 2012

    Report

    Report Number
    MW5025386
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 8, 2012
    Report Date
    May 10, 2012
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PLANNED EXTUBATION THE ETT COULD NOT BE WITHDRAWN. CUFF DEFLATED X2 AND STILL COULD NOT WITHDRAW. CUT LINE TO PORT USED TO INFLATE AND THEN WITHDREW ETT. BALLOON STILL HAD SOME AIR IN IT. THE TUBE WAS FOUND TO BE PINCHED BETWEEN THE ETT AND THE BITE PROOF BITE BOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE PROOF BITE BLOCK BITE BLOCK JXL B&B MEDICAL TECHNOLOGIES D133437

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other