BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA UNCUFFED EXTRA LENGTH FIXED HYPERFLEX ADULT TRACHEOSTOMY TUBE

    MDR report key: 2030350 · Received March 21, 2011

    Report

    Report Number
    2183502-2011-00084
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K081440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL ONCE IT IS COMPLETED.

    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 UNK 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 UNCUFFED EXTRA LENGTH FIXED HYPERFLEX ADULT TRACHEOSTOMY TUBE TRACHEOSTOMY TUBES JOH SMITHS MEDICAL ASD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK