BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO-ULTRA LITE NG

    MDR report key: 2603814 · Received May 30, 2012

    Report

    Report Number
    2603814
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 30, 2012
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A DOBHOFF TUBE PLACED IN ANTICIPATION OF TUBE FEEDINGS. AFTER PLACEMENT, AS THE GUIDE WIRE WAS BEING REMOVED, A SMALL PIECE OF WHAT LOOKED LIKE TUBING WAS EVIDENT ON THE GUIDE WIRE. THE TUBING WAS REMOVED, AND A SMALL TEAR WAS NOTED NEAR THE DISTAL END OF THE TUBING. ANOTHER TUBE WAS PLACED WITHOUT DIFFICULTY, AND THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO-ULTRA LITE NG TUBE, FEEDING FPD CORPAK MEDSYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR