BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIVONA

    MDR report key: 2298779 · Received October 7, 2011

    Report

    Report Number
    2298779
    Event Type
    Death
    Date Received
    October 7, 2011
    Date of Event
    September 26, 2011
    Report Date
    October 7, 2011
    Manufacturer
    SMITHS MEDICAL
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NOTED THAT THE CUFF OF THE BIVONA CUSTOM MADE ENDOTRACHEAL TUBE WAS NOT HOLDING THE 1 ML VOLUME OF WATER NOTED FROM THE PREVIOUS DAY. CLINICIANS NEEDED TO ADD 0.5 ML TO THE CUFF. THE INFANT DEVELOPED SEPSIS AND DIED A FEW DAYS LATER. IT IS UNKNOWN IF THIS WAS RELATED TO RESPIRATORY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Death