BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE

    MDR report key: 6526716 · Received April 27, 2017

    Report

    Report Number
    3012307300-2017-00918
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    March 31, 2017
    Report Date
    September 13, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006308
    PMA / PMN Number
    K083641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    PMA510(K): ADDITIONAL 510(K) NUMBER: K914088. 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

    DEVICE EVALUATION : ONE BIVONA SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING. IMMEDIATE VISUAL INSPECTION FOUND THAT THE SAMPLE HAD A SMALL HOLE IN THE DEVICE CUFF. LEAK TESTING OF THE SAMPLE ALSO DETECTED LEAKAGE FROM THE CUFF. TO FURTHER INVESTIGATE THE ISSUE, RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE. A REVIEW OF THE MANUFACTURING PROCESS WAS ALSO CONDUCTED AND WAS CONSIDERED ADEQUATE AND CORRECT. BASED ON THE EVIDENCE AND TESTING, THE COMPLAINT WAS CONFIRMED. THE EVENT PROBLEM SOURCE WAS TRACED TO MANUFACTURING RELATING TO DAMAGING THE UNIT UPON TAKING OUT SOME PARYLENE FLASH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUFF OF A BIVONA® PEDIATRIC TTS¿ TRACHEOSTOMY TUBE EXPERIENCED A LEAK AFTER THREE DAYS OF USE. THE LEAK WAS DISCOVERED DURING USE. CUFF INTEGRITY WAS TESTED PRIOR TO USE, AND AIR WAS USED TO INFLATE THE CUFF. A STANDARD TRACHEOSTOMY TUBE CHANGE WAS PERFORMED AFTER THE INCIDENT OCCURRED. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307596 BIVONA PEDIATRIC TTS TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3296321 15021312006308

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR