BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE

    MDR report key: 4230052 · Received October 10, 2014

    Report

    Report Number
    2183502-2014-00764
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    October 10, 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 EVAL 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 EVAL ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THE LISTED TRACHEOSTOMY TUBE WAS CHECKED FOR LEAKS PRIOR TO USE WITH NO LEAKS OBSERVED. AFTER ONE WEEK IN USE, THE DEVICE WAS REPORTEDLY FOUND LEAKING AT THE CUFF. NO PERMANENT ADVERSE EFFECTS TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642797 PORTEX 8.0MM SUCTIONAID TRACHEOSTOMY TUBE BTO - TRACHEOSTOMY TUBES BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK