BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIVONA TTS

    MDR report key: 444471 · Received February 10, 2003

    Report

    Report Number
    444471
    Event Type
    Death
    Date Received
    February 10, 2003
    Date of Event
    November 26, 2002
    Report Date
    February 10, 2003
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    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 PT HAD THE BIVONA TRACH PLACED EMERGENTLY IN 2002 FOR RESPIRATORY DISTRESS. 5 DAYS LATER PT DEVELOPED DECREASED OXYGEN SATURATION, STAFF DISCOVERED TRACH WAS DISPLACED. RESUSCIATION EFFORTS FAILED. INVESTIGATION REVEALED THE SLIDING LOCKABLE NECK FLANGE FAILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death