BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 10482921 · Received September 2, 2020

    Report

    Report Number
    3012307300-2020-08964
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 5, 2020
    Report Date
    December 7, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312006070
    PMA / PMN Number
    K944178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT TTS . VISUALLY INSPECTED FROM 12? -16? WITH NORMAL LIGHTING REVEALED BIG SPLIT AND CUT IN CUFF. RELEVANT DOCUMENTS WHICH WERE REVIEWED AND CORRECT FOR TESTING AND INSPECTION ACTIVITIES. PWI-10007254 REV.101 CLEAN/POSITION/ADHESIVE CUFF. PWI-10007269 REV.100 SYMMETRY AND LEAK TEST METHOD. PWI-10015937 REV. 100 SPRAY OF TEFLON AND INSERT VALVE. AV-10006853 REV.101 LEAK TESTING AND CUFF SYMMETRY VISUAL AID. 10018857-001 REV.100 IFU-ADULT TTS CUFF TRACHEOSTOMY. RMD-10001843 REV.100 PFMEA FOR BIVONA TRACHEOSTOMY TUBES. THE CAUSED AND THEORY AND CONSIDERATION WERE REVEALED AS: BAD ASSEMBLY, NOT FOLLOW THE INSTRUCTIONS. ? MANUFACTURING DEFECT FROM THE MOLDER. NO CORRECTIVE ACTIONS WERE TAKEN. HOWEVER, AS PART OF CONTAINMENT, PRODUCTION PERSONNEL WERE NOTIFIED BY QUALITY ENGINEER ON 10/NOV/2020 AS AWARENESS OF THE DEFECT REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES ADULT TTS MALFUNCTIONED. AFTER A WEEK IN USE, A TEAR IN THE CUFF WAS NOTED. NO ADVERSE PATIENT EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947967 BIVONA TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 670180 3869829 15021312006070

    Patients

    Seq Age Sex Outcome Treatment
    1