BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 10552562 · Received September 18, 2020

    Report

    Report Number
    3012307300-2020-09483
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 18, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15019517111606
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PICTURES CONFIRMED THAT THE EYELET TORE. A CONVERSATION BETWEEN THE CUSTOMER SERVICE REP AND THE CAREGIVER REVEALED THAT ANOTHER ACCESSORY BESIDES THE TWILL TAPE THAT IS PROVIDED WITH THE DEVICE IS BEING USED TO SECURE THE DEVICE TO THE END USER. THE IFU, IM-GAR-10018908-001 (FORMERLY PKG-DFU-CFX-2), STATES UNDER WARNINGS, ?GUARD AGAINST PRODUCT DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES. SOME TRACHEOSTOMY TUBE HOLDERS CONTAIN VELCRO OR METAL CLIPS WHICH MAY HAVE SHARP EDGES. THESE SHARP EDGES CAN COME INTO CONTACT WITH THE EYELETS AND COMPROMISE THE PRODUCT INTEGRITY." PROBLEM SOURCE WAS TRACED TO USER INTERFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT EYELET OF A PATIENTS SMITHS MEDICAL TRACH TUBE WAS SPLIT OPEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018323 BIVONA TRACHEOSTOMY TUBE JOH SMITHS MEDICAL ASD, INC. CMZ3232S BS006719 15019517111606

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention