BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6651178 · Received June 19, 2017

    Report

    Report Number
    3012307300-2017-01259
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 9, 2017
    Report Date
    December 8, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006094
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) - K083641 SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN, AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE.

    Additional Manufacturer Narrative · 1

    ONE PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WE RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY DEFECTS, ALTHOUGH IT APPEARED USED AND DISCOLORED. THE DEVICE WAS LEAK TESTED. NO LEAKS WERE DETECTED. INVESTIGATION OF THE DEVICE COULD NOT CONFIRM THE FAULT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAK IN THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE. AFTER NOTICING THE LEAK, THE PATIENT WENT INTO THE HOSPITAL AND HAD THE TRACHEOSTOMY TUBE REPLACED. THE STAFF IN THE HOSPITAL FILLED THE CUFF, AND OBSERVED WATER SLOWLY LEAKING OUT OF A SMALL HOLE. THE CUFF HAD BEEN CHECKED PRIOR TO BE INSERTED IN THE PATIENT, HOWEVER IT WAS IT NOTED THAT BECAUSE THE HOLE WAS SMALL, NO LEAKAGE WAS OBSERVED DURING THAT CHECK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432451 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006094

    Patients

    Seq Age Sex Outcome Treatment
    1