BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 7392948 · Received April 3, 2018

    Report

    Report Number
    3012307300-2018-00937
    Event Type
    Malfunction
    Date Received
    April 3, 2018
    Date of Event
    March 7, 2018
    Report Date
    January 10, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006032
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE ENDOTRACHEAL TUBE WAS RETURNED FOR EVALUATION. THE INFLATION BALLOON WAS MISSING FROM THE DEVICE. IT UNDERWENT FUNCTIONAL TESTING BY USING MAGNIFICATION, AND THE AIRWAY LINE APPEARED TO BE BROKEN AT THE BALLOON JUNCTION. WHILE NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING NO ADVERSE HEALTH OUTCOME TO PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL 510(K) - K083641. THIS DEVICE IS SAME AND/OR SIMILAR TO A DEVICE APPROVED FOR DISTRIBUTION IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PILOT LINE OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE BROKE AFTER TWO DAYS IN USE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236943 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3451043 15021312006032

    Patients

    Seq Age Sex Outcome Treatment
    1