BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA

    MDR report key: 601181 · Received May 5, 2005

    Report

    Report Number
    MW1035402
    Event Type
    Injury
    Date Received
    May 5, 2005
    Date of Event
    April 20, 2005
    Report Date
    May 5, 2005
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH SEVERE RESPIRATORY DISEASE WHO HAD BIVONA TRACHEOSTOMY TUBE IN PLACE. PT REQUIRED AN MRI SCAN OF THE HEAD. TEST COULD NOT BE PERFORMED AS BIVONA TRACHEOSTOMY TUBES CONTAIN METAL. TRACHEOSTOMY TUBE NEEDED TO BE CHANGED TO A SHILEY TUBE IN ORDER PERFORM MRI SCAN. THERE IS NO WRITTEN WARNING ON THE PACKAGE BOX OR THE PRODUCT PACKAGE INDICATING THE TUBE CONTAINS METAL, OR THAT AN MRI IS CONTRAINDICATED. IT IS HOWEVER MENTIONED ON THE PACKAGE INSERT THAT THE TUBE IS WIRE REINFORCED, AND AN MRI IS CONTRAINDICATED. THE BIVONA FIXED FLANGE HYPERFLEX EXTRA LONG TUBE - USED IN ADULT PTS - ALSO CONTAIN METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA PEDIATRIC/NEONATAL TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES 65N030 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Life Threatening