BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTRACHEAL TUBE INTRODUCER

    MDR report key: 4479288 · Received January 15, 2015

    Report

    Report Number
    1036445-2015-00001
    Event Type
    Injury
    Date Received
    January 15, 2015
    Date of Event
    December 2, 2014
    Report Date
    January 15, 2015
    Manufacturer
    FBK MEDICAL
    Product Code
    BSR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADVERSE PATIENT EVENT INVOLVING A BOUGIE TIP (USED FOR INTUBATION) THAT BROKE INSIDE OF PATIENT, LODGED IN LUNG, REQUIRED BRONCHOSCOPY AT BEDSIDE WITH PROLONGED INTENSIVE CARE AND HOSPITALIZATION. ORIGINAL MEDWATCH REPORT SUBMITTED BY (B)(6) MEDICAL CENTER ON (B)(6) 2014. THE HOSPITAL PERSONNEL CONFIRMED THAT THE LOT NUMBER WAS REPORTED INCORRECTLY. IT IS PRN05-3445.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37513 ENDOTRACHEAL TUBE INTRODUCER ET TUBE INTRODUCER/BOUGIE BSR FBK MEDICAL 9-0212-70 PRN05-3445

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R