BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA MEDICAL TECHNOLOGIES

    MDR report key: 336056 · Received May 31, 2001

    Report

    Report Number
    336056
    Event Type
    Injury
    Date Received
    May 31, 2001
    Date of Event
    May 20, 2001
    Report Date
    May 30, 2001
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    AT 11:30AM, PARENT HEARD AN "UNUSUAL" SOUND COMING FROM PT'S TRACH. UPON CLOSER INSPECTION, PARENT NOTED THAT PT'S TRACH WAS "SPLIT". PARENT IMMEDIATELY REMOVED THE SPLIT TRACH AND REPLACED IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25110 BIVONA MEDICAL TECHNOLOGIES TRACHEOSTOMY TUBE BTO BIVONA MEDICAL TECHNOLOGIES 60P035 1022830

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention