BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA ADULT TTS TRACHEOSTOMY TUBES

    MDR report key: 5093809 · Received September 22, 2015

    Report

    Report Number
    2183502-2015-00684
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 22, 2015
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    PMA / PMN Number
    K083641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    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. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DAMAGE. ATTEMPT TO INFLATE THE SAMPLE WITH 12 CC OF AIR FAILED AS CUFF WOULD NOT STAY INFLATED. LEAK TEST WAS PERFORMED BY SUBMERGING THE UNIT UNDER WATER WHILE INSERTING AIR THROUGH THE INFLATION LINE. UNIT REVEALED PINHOLE FRACTURE ON THE AIRWAY LINE ALONG THE SHAFT. LOCATION OF HOLE WAS FOUND TO BE 12 MM FROM BOTTOM OF THE NECK STRAP ON THE PROXIMAL END OF THE SHAFT. IT IS UNLIKELY THAT THIS HOLE WAS PRESENT PRIOR TO USE AS THE DEVICES ARE 100% LEAK TESTED IN MANUFACTURING PRIOR TO PACKAGING. CUSTOMER REPORTED THAT UNIT WAS IN USE 6-12 HOURS BEFORE THE LEAK WAS FELT BY THE PATIENT. LIKELY CAUSE OF THE PIN HOLE IS A ROUGH SPOT IN THE PATIENT'S ANATOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD BEEN LEAK TESTED PRIOR TO USE. AFTER ABOUT 6-12 HOURS OF USE, THE PATIENT INFORMED HOSPITAL PERSONNEL THAT SHE COULD FEEL FLUID LEAKING DOWN HER NECK. NO ADVERSE HEALTH OUTCOME RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626694 BIVONA ADULT TTS TRACHEOSTOMY TUBES TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1