BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA SILICONE TRACHEOSTOMY TUBE

    MDR report key: 18667629 · Received February 7, 2024

    Report

    Report Number
    MW5151159
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 5, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE BALLOON THAT INFLATED UNEVENLY ON PEDIATRIC TRACH. BIVONA SILICONE TRACHEOSTOMY TUBE REF: 67SP035 LOT: 4289477, EXP: 09/13/2027. THIS DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365023 BIVONA SILICONE TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 4289477

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Other