BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B&B BITE PROOF BITE BLOCK

    MDR report key: 660958 · Received December 20, 2005

    Report

    Report Number
    MW1037475
    Event Type
    Malfunction
    Date Received
    December 20, 2005
    Date of Event
    August 19, 2005
    Report Date
    December 20, 2005
    Manufacturer
    B&B MEDICAL TECHNOLOGIES INC.
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON TWO OCCASIONS A RESPIRATORY THERAPIST FOUND THE BITE BLOCK PORTION OF THE B&B BITE PROOF BITE BLOCK SLIPPED DOWN A PT'S ENDOTRACHEAL TUBE IN THE BACK OF THE PT'S THROAT. A SMALL PART OF THE WHITE PORTION OF THE DEVICE WAS VISIBLE INSIDE THE PT'S MOUTH SO SHE LOOKED DOWN THE ETT AND FOUND THE BITE BLOCK. THIS COULD POSE A HAZARD TO INTUBATED PATIENTS. THERE WAS NO INJURY RELATED TO THESE INCIDENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR