BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA TTS

    MDR report key: 478333 · Received August 12, 2003

    Report

    Report Number
    478333
    Event Type
    Injury
    Date Received
    August 12, 2003
    Date of Event
    August 2, 2003
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BIVONA TRACH SLIPPED IN ITS HOLDER AND CONSEQUENTLY MIGRATED OUT OF THE TRACHEA WHICH ALLOWED MATERIAL INTO THE TRACHEA TO OCCLUDE THE TIP OF THE TUBE. THE BIVONA TUBE WAS A DEFECTIVE DEVICE BECAUSE IT FAILED TO HAVE A MURPHY OPENING OR SECOND OPENING LOCATED ON THE SIDE OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TTS ADJUSTABLE NECK FLANGE HYPERFLEX TRACH TUBE JOH BIVONA MEDICAL TECHNOLOGIES CE 0473 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| S