BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 8.0MM VOCALAID TRACHEOSTOMY TUBE

    MDR report key: 3983924 · Received June 24, 2014

    Report

    Report Number
    2183502-2014-00432
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 24, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ALLEGING THAT HT TRACHEOSTOMY TUBE WAS LEAKING AT THE CUFF AFTER SIX HOURS IN SITU. REPLACEMENT WAS REQUIRED AFTER THREE DAYS USE, AS THE CUFF ALLEGEDLY BECAME FULLY DEFLATED. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368077 PORTEX 8.0MM VOCALAID TRACHEOSTOMY TUBE BTO - TRACHEOSTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD NA 2636625

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK