BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO ULTRA NG FEEDING TUBE

    MDR report key: 7769700 · Received August 9, 2018

    Report

    Report Number
    7769700
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Report Date
    August 3, 2018
    Manufacturer
    CORPAK MEDSYSTEMS, INC.
    Product Code
    FPD
    UDI-DI
    10815149023516
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CORPAK CORFLO ENTERAL FEEDING TUBE GUIDEWIRE AND TUBING KINKED, UNABLE TO FLUSH OR USE. REF 20-7431AIV2, LOT 79540, (B)(4). TUBE REMOVED AND REPLACED WITH EFFECTIVE DEVICE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611700 CORFLO ULTRA NG FEEDING TUBE TUBE, FEEDING FPD CORPAK MEDSYSTEMS, INC. 20-7431AIV2 79540 10815149023516

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA