BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B&B MEDICAL TECHNOLOGIES - UNIVERSAL BITE BLOCK

    MDR report key: 2875032 · Received November 20, 2012

    Report

    Report Number
    2875032
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 20, 2012
    Manufacturer
    INTEGRA BIOTECHNICAL, LLC
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST (RT) AND A RN WITNESSED THAT THE "PROTECTIVE BLUE PIECE" AT THE END OF THE STIFF TIE ON THE BITE BLOCK HAD FALLEN OFF AND LANDED IN A PATIENT'S MOUTH. RT SUPERVISOR CHECKED THE DEVICE AND FOUND THAT THE TIP DOES INDEED DISLODGE FAIRLY EASILY. HAD IT NOT BEEN FOR RT AND RN ATTENTION TO DETAIL, THAT PIECE COULD HAVE BEEN ASPIRATED BY THE PATIENT WITH POTENTIALLY DISASTROUS CONSEQUENCES. THIS EVENT HAS OCCURRED ON MORE THAN ONE OCCASION RESULTING IN NEAR ASPIRATION OF THE SMALL PART.

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST (RT) AND A RN WITNESSED THAT THE "PROTECTIVE BLUE PIECE" AT THE END OF THE STIFF TIE ON THE BITE BLOCK HAD FALLEN OFF AND LANDED IN A PATIENT'S MOUTH. RT SUPERVISOR CHECKED THE DEVICE AND FOUND THAT THE TIP DOES INDEED DISLODGE FAIRLY EASILY. HAD IT NOT BEEN FOR RT AND RN ATTENTION TO DETAIL, THAT PIECE COULD HAVE BEEN ASPIRATED BY THE PATIENT WITH POTENTIALLY DISASTROUS CONSEQUENCES. THIS EVENT HAS OCCURRED ON MORE THAN ONE OCCASSION RESULTING IN NEAR ASPIRATION OF THE SMALL PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B&B MEDICAL TECHNOLOGIES - UNIVERSAL BITE BLOCK ENDOSCOPIC BITE BLOCK JXL INTEGRA BIOTECHNICAL, LLC FOR TUBE SIZE 6MM TO 9.5 MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * OTHER