BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES

    MDR report key: 6477378 · Received April 10, 2017

    Report

    Report Number
    3012307300-2017-00829
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Report Date
    April 10, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312005554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K913859 AND K083641. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBE FLANGES RIPPED OPEN, WHICH CAUSED THE TUBE TO BE DISLODGED AT THE SITE WHERE THE TRACHEOSTOMY TUBE TIES WERE THREADED THROUGH. THE PATIENT WAS USING POSEY TRACHEOSTOMY TUBE TIES WHEN THE EVENT OCCURRED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A HISTORY OF PULLING THE TUBE OR MANIPULATING THE TUBE TIES, AND THE TIES WERE NOT TIED TIGHTER THAN RECOMMENDED. THE DEVICE WAS USED FOR UP TO ONE MONTH PRIOR TO BEING SANITIZED VIA LIGHT RINSING AND BOILING WATER UP TO TWO TIMES BEFORE THE FAILURE OCCURRED. THE TUBE WAS REPLACED WITH A NEW TUBE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00828.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257913 PORTEX® BIVONA® UNCUFFED ADULT TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 2720352 15021312005554

    Patients

    Seq Age Sex Outcome Treatment
    1