BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TRACHEOSTOMY TUBE

    MDR report key: 2232919 · Received July 21, 2011

    Report

    Report Number
    2183502-2011-00546
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE REQUIRED REMOVAL AND REPLACEMENT. IT IS ALLEGED THAT AFTER AN UNKNOWN AMOUNT OF TIME IN SITU THE TRACHEOSTOMY TUBE TORN NEAR THE FLANGE REQUIRING REPLACEMENT. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR