BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES

    MDR report key: 5921089 · Received September 1, 2016

    Report

    Report Number
    2183502-2016-01864
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Report Date
    August 4, 2016
    Manufacturer
    SMITHS MEDICAL ASD INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    A 510(K): 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 ADULT TTS TRACHEOSTOMY TUBE WOULD NOT CONNECT TO STANDARD TRACHEOSTOMY TUBE ADAPTORS FOR VENTILATORS WITH EASE. THE CUSTOMER TRIED FIVE DIFFERENT ADAPTORS FOR USE. THE ISSUE OCCURRED WITH A NEW TRACHEOSTOMY TUBE PATIENT WHILE TUBE WAS IN SITU. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573700 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD INC. 3048301

    Patients

    Seq Age Sex Outcome Treatment
    1