BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ET INTRODUCER COUDE TIP

    MDR report key: 2623141 · Received April 18, 2009

    Report

    Report Number
    2183650-2009-00001
    Event Type
    Injury
    Date Received
    April 18, 2009
    Date of Event
    March 2, 2009
    Report Date
    April 17, 2009
    Manufacturer
    MEDITEC DEVICES
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INTRODUCER WAS BEING USED AS AN EXCHANGER. DEVICE WAS INSERTED TO REMOVE THE BRONCHO CATHETER AND A 3/4" LONG PIECE BROKE OFF THE DEVICE. THE PIECE WAS RETRIEVED AND A NEW TUBE WAS PLACED INSIDE SUCCESSFULLY. PER (B)(6), THE DEVICE HAD BEEN REUSED SEVERAL TIMES AND WIPED DOWN WITH ALCOHOL EACH TIME. THE DEVICE WAS DISCOLORED AND DRIED OUT. THE DEVICE IS CLEARLY LABELED AS FOR SINGLE USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ET INTRODUCER COUDE TIP BSR MEDITEC DEVICES 9-0212-70 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention