BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 4201052 · Received September 16, 2014

    Report

    Report Number
    2183502-2014-00691
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD,
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 RECEIVED STATING THAT THE LISTED TRACHEOSTOMY TUBE WAS FOUND LEAKING AT THE CUFF AFTER AN UNK AMOUNT OF TIME IN SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572373 PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE BTO-TRACHEOSTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD, NA 2676993

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK