BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO-ULTRA

    MDR report key: 5938750 · Received September 9, 2016

    Report

    Report Number
    5938750
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    July 16, 2016
    Report Date
    August 30, 2016
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NASOGASTRIC TUBE (NGT) WAS REPLACED IN PATIENT AND WHEN ATTEMPTING TO OBTAIN AN ASPIRATE IT WAS FOUND THAT THE TOP 1.5 CM OF TUBING WAS TORN OPEN AND NGT HAD TO BE REPLACED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590269 CORFLO-ULTRA TUBE, FEEDING FPD CORPAK MEDSYSTEMS 20-8366

    Patients

    Seq Age Sex Outcome Treatment
    1