BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITE PROOF BITE BLOCK

    MDR report key: 6285520 · Received January 30, 2017

    Report

    Report Number
    6285520
    Event Type
    Malfunction
    Date Received
    January 30, 2017
    Date of Event
    December 22, 2016
    Report Date
    January 18, 2017
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC.
    Product Code
    JAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE ET TUBE WAS BEING ADVANCED, PATIENT BECAME AGITATED AND THE BLUE CAP ON THE ZIP TIE THAT HOLDS THE HOLLISTER ENDOTRACHEAL TUBE HOLDER (BITE BLOCK) FELL INTO PATIENT'S MOUTH. RN AND RESPIRATORY THERAPIST USED FLASHLIGHT TO TRY TO LOCATE CAP WITHOUT SUCCESS. THE DOCTOR WAS NOTIFIED AND ENT CONSULT ORDERED. BEFORE ENT ARRIVED, THE PATIENT COUGHED AND CAP WAS THEN VISIBLE IN MOUTH AND WAS REMOVED. NO HARM TO PATIENT. BEING DISCUSSED IN SYSTEMWIDE RT MTG RE DANGER OF THIS SMALL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70345 BITE PROOF BITE BLOCK SUPPORT, BREATHING TUBE JAY B & B MEDICAL TECHNOLOGIES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other