BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CUFF 7.5MM TRACHEOSTOMY TUBE

    MDR report key: 3881194 · Received February 12, 2014

    Report

    Report Number
    2183502-2014-00026
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    February 11, 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. THE ACTUAL DEVICE INVOLVED WAS RETURNED AND IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE TRACHEOSTOMY TUBE WAS DEFLATING AT THE CUFF AFTER AN UNKNOWN AMOUNT OF TIME IN SITU. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92696 PORTEX CUFF 7.5MM TRACHEOSTOMY TUBE BTO-TRACHOESTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK