BEUDAMED
    FDA Adverse Event Other Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 752654 · Received May 11, 2005

    Report

    Report Number
    MW1035453
    Event Type
    Other
    Date Received
    May 11, 2005
    Date of Event
    May 4, 2005
    Report Date
    May 11, 2005
    Manufacturer
    B& B MEDICAL TECHNOLOGIES
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT INTUBATED FOR PNEUMONIA. A BITE BLOCK WAS PLACED COINCIDENT WITH ETT PLACEMENT. TWO WEEKS AFTERWARD A PERSISTENT LEAK WAS NOTED WHICH COULD NOT BE RESOLVED WITH REINFLATION OF THE ETT CUFF AND ONLY 3 CC OF AIR COULD BE INFLATED AT ANY TIME. THE PATIENT EXPERIENCED OXYGEN DESATURATION INTERMITTENTLY BUT NO OTHER SEQUELAE. THE PATIENT WAS SCHEDULED FOR TRACHEOSTOMY BECAUSE OF PROLONGED INTUBATION. IT WAS ASSUMED THAT THE ETT CUFF WAS MALFUNCTIONING. AT TRACHEOSTOMY, THE ETT WAS REMOVED REVEALING OBSTRUCTION BY THE BITE BLOCK OF THE SOFT PLASTIC TUBING BETWEEN THE PILOT BALLOON AND THE ETT CUFF. THIS OCCURRED WITH USUAL PLACEMENT OF THIS COMBINATION OF THE ETT AND BITE BLOCK. THIS CAUSED DIFFICULTY FULLY INFLATING AND DEFLATING THE ETT CUFF WITH RESULTANT INCOMPLETE SEAL OF THE CUFF WITH THE TRACHEA AND AN AIR LEAK AS WELL AS AN INCOMPLETELY DEFLATED ETT CUFF UPON EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE PROOF BITE BLOCK BITE BLOCK JXL B& B MEDICAL TECHNOLOGIES * 000105

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other NOT RELEVENT