BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 4612282 · Received March 17, 2015

    Report

    Report Number
    1036445-2015-00002
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    January 22, 2015
    Report Date
    February 24, 2015
    Manufacturer
    FBK MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO EXCHANGE ENDOTRACHEAL TUBES IN AN ICU PATIENT, THE PHYSICIAN INTRODUCED THE INTRODUCER INTO THE PATIENT'S EXISTING ET TUBE. THE TYPE OF THE INTRODUCER BROKE OFF, BECOMING LODGED IN THE DISTAL END OF THE ET TUBE. THE ET TUBE WAS ABLE TO BE REMOVED WITH THE BROKEN TIP STILL INSIDE THE ET TUBE, WITHOUT FURTHER INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182531 ENDOTRACHEAL TUBE INTRODUCER ET TUBE INTRODUVER/BOUGIE BSR FBK MEDICAL 9-0212-70 PRN04-2999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention