BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E080845

    MDR report key: 641397 · Received October 4, 2005

    Report

    Report Number
    641397
    Event Type
    Malfunction
    Date Received
    October 4, 2005
    Date of Event
    August 8, 2005
    Report Date
    October 4, 2005
    Manufacturer
    RUSCH, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    THE MORNING AFTER THE FEEDING TUBE WAS INSERTED AND PLACEMENT WAS VERIFIED BY XRAY, IT WAS NOTED THAT THE FEEDING WAS LEAKING FROM THE AIR-VALVE. THE TUBE WAS REMOVED AND A NEW ONE WAS REINSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E080845 GASTRIC FEEDING TUBE FPD RUSCH, INC. E080845 024609-2

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR