BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 2578399 · Received May 9, 2012

    Report

    Report Number
    MW5025384
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 18, 2012
    Report Date
    May 9, 2012
    Manufacturer
    B AND 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

    BITE PROOF BITE BLOCK FOR ENDOTRACHEAL TUBES SIZE 6 TO 9.5MM WAS USED. MFG BY INTEGRA BIOTECHNICAL, LLC FOR B AND B MEDICAL TECHNOLOGIES. LOT # D133437. THE TUBING FROM THE PILOT BALLOON PORT WAS PLACED BETWEEN THE ETT AND THE BITE BLOCK PER MFR INSTRUCTIONS. THE TUBING BECAME KINKED AND THE BALLOON COULD NOT BE INFLATED. THE ETT HAD TO BE REMOVED AND THE PT WAS RE-INTUBATED. THE PT DIED ON (B)(6) 2012, BUT IT IS UNCLEAR IF THE KINKED TUBE HAD A SIGNIFICANT ROLE IN THE OUTCOME. HOWEVER, THE FACT REMAINS THAT THE MEDICAL STAFF HAD TO RE-INTUBATE THE PT WITH A NEW ETT AND WHEN EXAMINING THE ETT THAT WAS INITIALLY USED IT WAS FOUND THAT THE TUBE WAS KINKED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other