BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B&B MEDICAL TECHNOLOGIES

    MDR report key: 2558021 · Received April 20, 2012

    Report

    Report Number
    MW5025231
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    April 7, 2012
    Report Date
    April 20, 2012
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    JAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH NOTED CUFF LEAK IN ENDOTRACHEAL TUBE. PILOT BALLOON FULLY INFLATES. PT EXTUBATED. IT WAS NOTED THAT THE BITE BLOCK HAD SLIPPED AND WAS BLOCKING OFF THE PILOT TUBING TO THE ETT. CUFF WAS ONLY PARTIALLY INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B&B MEDICAL TECHNOLOGIES UNIVERSAL BITE BLOCK JAY B&B MEDICAL TECHNOLOGIES D116817

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR