BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO ULTRA NG 8FR

    MDR report key: 3173249 · Received June 6, 2013

    Report

    Report Number
    3009124963-2013-00021
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED. NO LOT NUMBER WAS REPORTED AND NO SAMPLE RETURNED. RESERVE SAMPLES WERE BOTH VISUALLY AND MECHANICALLY TESTED. IN ORDER TO DUPLICATE A SIMILAR BREAK, MORE THAN 7LBS OF TENSILE FORCE WAS APPLIED TO THE FEEDING TUBES. IT IS UNCLEAR HOW THESE TYPES OF FORCES COULD BE APPLIED TO THE TUBE DURING CLINICAL USE.

    Description of Event or Problem · 1

    EVENT DESC: THE FEEDING TUBE HAD BROKEN OFF AT APPROXIMATELY 6-7CM FROM THE TIP OF THE TUBE. THE SEPARATED TUBE WAS EXCRETED WITH STOOL. SINCE THE PATIENT HAS AN INFECTION DISEASE, THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251948 CORFLO ULTRA NG 8FR FEEDING TUBE (NASOGASTRIC TUBE) KNT CORPAK MEDSYSTEMS EDA 7488 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK