BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIVONA CUSTOM CUFFLESS FLEXTEND TRACHEOSTOMY TUBE

    MDR report key: 4102582 · Received September 12, 2014

    Report

    Report Number
    2183502-2014-00653
    Event Type
    Injury
    Date Received
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SMITHS MEDICAL, INC.
    Product Code
    JOH
    PMA / PMN Number
    K923878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: CUSTOMER HAS NOT YET RETURNED DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE LISTED DEVICE KINKED AFTER AN UNK AMOUNT OF TIME IN USE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE REPORTED EVENT. ADDITIONAL INFO HAS BEEN REQUESTED, NO FURTHER INFO HAS BEEN RECEIVED AT THIS TIME. NO PERMANENT ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565062 BIVONA CUSTOM CUFFLESS FLEXTEND TRACHEOSTOMY TUBE JOH, TRACHEOSTOMY TUBE JOH SMITHS MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention