BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 2940518 · Received December 20, 2012

    Report

    Report Number
    2183502-2012-00613
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    December 18, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    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

    A REPORT WAS RECEIVED THAT ALLEGES THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER 4 HOURS IN SITU. REPLACEMENT WAS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA CL108659

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK