BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA

    MDR report key: 10200321 · Received June 26, 2020

    Report

    Report Number
    3012307300-2020-06267
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Report Date
    August 25, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    UDI-DI
    15021312000368
    PMA / PMN Number
    K912469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    3/3 REFERENCE CC-0073132 FOR ALL ATTACHMENTS AND RELATED COMPLAINTS. DAMAGE TO THE HUB WAS FOUND AFTER ONE WEEK OF USE. CAREGIVER STATES THAT PROPER CLEANING PROCEDURES ARE FOLLOWED AND NO EXTERNAL ATTACHMENTS ARE BEING USED. PICTURES ATTACHED. ADDITIONAL INFORMATION RECEIVED 01 JUNE 2020 BY PHONE CALL: THE TWO DEVICES THAT WERE SENT IN ALSO HAD THE SAME ISSUE AS ABOVE. THE TEAR WAS FOUND IN THE SAME PLACE IN ALL THREE TRACHS. THE PATIENT'S MOTHER DID NOT DO TRACH CHANGES STATING THAT THE PATIENT WAS NOT IN DISTRESS. NORMAL TRACH CHANGES WERE DONE WHEN THE PATIENT WAS DUE FOR HER TRACH CHANGES. INVESTIGATION COMPLETED AND IN H 1-.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT ONE WEEK FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX BIVONA TRACHEOSTOMY TUBE, A TEAR TO THE HUB WAS FOUND. IT WAS REPORTED THAT PROPER CLEANING PROCEDURES WERE FOLLOWED, AND NO EXTERNAL ATTACHMENTS HAD BEEN USED. THE PATIENT WAS REPORTED TO NOT BE IN DISTRESS, SO NO TRACH TUBE CHANGE OUT WAS REQUIRED. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664924 BIVONA TRACHEOSTOMY JOH SMITHS MEDICAL ASD, INC. 60SP030 3877643 15021312000368

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR