BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM 3.0 FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 1901491 · Received November 9, 2010

    Report

    Report Number
    2183502-2010-00531
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SIMTHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    ACCORDING TO REPORTER, A SUCTION CATHETER COULD NOT BE PASSED THROUGH THE PRODUCT DURING USE. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM 3.0 FLEXTEND TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SIMTHS MEDICAL ASD, INC. NA CL82064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK