BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B & B BITE PROOF BITE BLOCK

    MDR report key: 342495 · Received July 17, 2001

    Report

    Report Number
    MW1022407
    Event Type
    Malfunction
    Date Received
    July 17, 2001
    Date of Event
    July 10, 2001
    Report Date
    July 17, 2001
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BITE BLOCK HAD BEEN PLACED TO PREVENT PT FROM BITING ENDOTRACHEAL TUBE DURING SUCTIONING (PER RN GOING OFF DUTY REPORT). WHEN RN ASSESSED PT NOTED PT WAS BITING ON ET TUBE. RN OBSERVED BIT BLOCK IN PT MOUTH, ABLE TO EXTRACT FROM BACK OF THROAT WITH HEMOSTATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32295 B & B BITE PROOF BITE BLOCK BITE BLOCK JXL B & B MEDICAL TECHNOLOGIES, INC * 010101

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other