BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE

    MDR report key: 6602678 · Received May 31, 2017

    Report

    Report Number
    3012307300-2017-01145
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 9, 2017
    Report Date
    December 6, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBERS: 3246161, 3230578, AND 3233460. ADDITIONAL 510(K) NUMBER: K083641. THE DEVICE IS CURRENTLY BEING EVALUATED; SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. DEVICE EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    ONE PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE IDENTIFIED WEAR IN THE CUFF ON THE UNDERSIDE OF THE CURVE. A LEAK WAS IDENTIFIED IN THE CUFF. THERE WERE ABRASION MARKS SURROUNDING THE CUT/TEAR IN THE CUFF. OTHER AREAS OF THE CUFF DID NOT EXHIBIT ABRASION MARKS. THE LOT PASSED A 100% LEAK TEST PERFORMED BY MANUFACTURING AND A SAMPLE LEAK TEST INSPECTION BY QUALITY. THE INVESTIGATION COULD NOT DETERMINE WHAT CAUSED THE ABRASION MARKS ON THE CUFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE WAS LEAKING AFTER FIVE HOURS IN USE. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A PREVIOUSLY USED TRACHEOSTOMY TUBE. THERE WAS NO LEAKING OBSERVED ONCE THE PREVIOUSLY USED TRACHEOSTOMY TUBE WAS PLACED. THE REPORTER NOTES THE ISSUE MIGHT NOT BE CAUSED BY PATIENT ANATOMY OR CALCIFIED PLAQUE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383863 PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1