BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA-PORTEX

    MDR report key: 1923963 · Received December 9, 2010

    Report

    Report Number
    MW5018544
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 20, 2010
    Report Date
    December 2, 2010
    Manufacturer
    SMITHS MEDICAL
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS CLIENT IS VENTILATOR DEPENDENT AND RECEIVED SIMV VOLUME VENTILATION. THE CLIENT'S TRACH CUFF LEAKED WATER CAUSING AN AIR LEAK AND REDUCED TIDAL VOLUME. NURSE IN HOME CHANGED TRACH EMERGENTLY TO AVOID INJURY TO THE CLIENT. THE FAMILY REPROCESSES/REUSES TRACHS FOR THIS CLIENTS, BUT THIS WAS REPORTEDLY, THE FIRST-TIME USE OF THIS TRACH TUBE. IN ADDITION TO THIS EVENT, SIMILAR EVENTS HAPPENED WITH THE SAME SIZE AND MFR OF TRACH ON FIVE OCCASIONS IN (B)(6) AND (B)(6) 2010, BUT THE LOT NUMBERS WERE UNAVAILABLE TO REPORT. THE MFR WAS NOTIFIED, AND ALL FIVE TRACHS WERE REPLACED BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA-PORTEX 7.0 I.D. ADULT BIVONA FLEX CUFFED TRACH JOH SMITHS MEDICAL TTS CL 83631

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention