BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11028288 · Received December 17, 2020

    Report

    Report Number
    3012307300-2020-12516
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 13, 2020
    Report Date
    January 18, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) REVEALED PICTURE THREE WITH DAMAGE PRESENT IN THE CUFF. FUNCTIONAL TESTING DONE WITH SAMPLE PN:100/810/075 WHICH REVEALED LEAKING AFTER INFLATING AIR INTO CUFF AND SUBMERGING INTO WATER. AIR BUBBLES WERE REVEALED AND CONFIRMED COMPLAINT. ENGINEERING MANUFACTURING WAS REVIEWED AND PRODUCT TESTED AT 100% PRIOR TO LEAVING MANUFACTURING. THE ROOT CAUSE IS THAT THE CUFF WAS DAMAGED AFTER IT LEFT THE SHM FACILITIES DUE TO THE PRODUCT IS 100% USON LEAK TESTED.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARY IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT AIR LEAKED AFTER INSERTING THE PORTEX TUBE BLUE LINE ULTRA IN TO THE PATIENT EVEN THOUGH IT FUNCTIONED PROPERLY WHEN IT WAS CHECKED PRIOR TO USE. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498689 PORTEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/860/075 3779767

    Patients

    Seq Age Sex Outcome Treatment
    1