BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX TRACHEOSTOMY TUBE

    MDR report key: 4821540 · Received June 1, 2015

    Report

    Report Number
    2183502-2015-00391
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Report Date
    June 1, 2015
    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

    DEVICE EVALUATION: 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 F/U REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS. MECHANICAL TESTING WAS PERFORMED BY INFLATING AND DEFLATING THE CUFF TO OBSERVE FOR ANY LEAKS. NO LEAKS WERE FOUND DURING TESTING. UNIT PERFORMED AS INTENDED. UNABLE TO CONFIRM THE REPORTED EVENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THE LISTED TRACHEOSTOMY TUBE WAS TESTED FOR LEAKS PRIOR TO USE WITH NO LEAKS DETECTED. AFTER TWO WEEKS IN USE, THE CUFF WAS FOUND TO NOT INFLATE. NO INCIDENT RELATED MEDICAL SEQUELA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351870 PORTEX TRACHEOSTOMY TUBE BTO - TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK