BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM 3.5 FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 2000010 · Received February 17, 2011

    Report

    Report Number
    2183502-2011-00044
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 16, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AN 8 FR AIRLIFE SUCTION CATHETER COULD NOT BE PASSED THROUGH THE PRODUCT DURING USE. NO LONG TERM INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM 3.5 FLEXTEND TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CL81178

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK