BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

    MDR report key: 3820744 · Received May 1, 2014

    Report

    Report Number
    2183502-2014-00264
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTO
    PMA / PMN Number
    K083031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF RETURNED DEVICE FOUND NO ISSUES. FUNCTIONAL TESTING PERFORMED ON RETURNED SAMPLE OBSERVED LEAKAGE AT THE CONNECTION OF THE INFLATION LINE AND TRACHEOSTOMY TUBE. THE DEVICE LISTED IS 100% LEAK-TESTED DURING MANUFACTURING PROCESS; THE DEVICE CUFF IS INFLATED AND LEFT FOR 12 HOUR PERIOD AND ANY DEVICES SHOWING REDUCED CUFF VOLUME AFTER THIS TIME PERIOD ARE REJECTED AND SCRAPPED. THE MANUFACTURER'S INVESTIGATION DETERMINED THAT IF THE DAMAGE TO THE INFLATION LINE LUMEN HAD BEEN PRESENT DURING MANUFACTURE THE DEVICE WOULD HAVE BEEN SCRAPPED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE DEVICE WAS IN USE FOR THREE DAYS WHEN THE CUFF WAS FOUND LEAKING. A TRACHEOSTOMY TUBE CHANGE WAS PERFORMED. THERE WERE NO ADVERSE EFFECTS TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262498 PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE BTO - TRACHEOSTOMY TUBE, CLINICAL-USE, SINGLE-USE BTO SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK