BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FROVA INTUBATING INTRODUCER

    MDR report key: 9929022 · Received April 6, 2020

    Report

    Report Number
    3005580113-2020-00348
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    March 7, 2020
    Report Date
    April 6, 2020
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    BTR
    UDI-DI
    10827002236469
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: BTR TUBE, TRACHEAL (W/WO CONNECTOR). PRODUCT CODE: BTR.

    Description of Event or Problem · 1

    EVENT DESCRIPTION ACCORDING TO THE CUSTOMER COMMENTS: "PT WAS BEING INTUBATED PRIOR TO EGD PROCEDURE. FROVA INTUBATING INTRODUCER BROKE DURING REMOVAL FROM THE PTS AIRWAY LEAVING ABOUT 20 CM OF THE INTRODUCER IN THE PTS LUNG. THE ET TUBE WAS SUCCESSFULLY PLACED AND THE PATIENTS AIRWAY WAS MAINTAINED WHILE ATTEMPTS WERE MADE TO REMOVE THE OBJECT FROM THE PT. THE OBJECT WAS SUCCESSFULLY REMOVED AFTER SEVERAL ATTEMPTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394443 FROVA INTUBATING INTRODUCER BTR WILLIAM COOK EUROPE E3666617 10827002236469

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention