BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO 8FR X 43 " ENTERAL FEEDING TUBE

    MDR report key: 5238802 · Received November 20, 2015

    Report

    Report Number
    3009124963-2015-00033
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    August 4, 2015
    Report Date
    November 19, 2015
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INJURY. NO SAMPLE OR LOT NUMBER REPORTED, THEREFORE NO INVESTIGATION COULD BE PERFORMED. THE PART NUMBER WAS UNKNOWN. THE PART NUMBER USED WAS DETERMINED FROM FREQUENT FEEDING TUBE ORDERS BY CUSTOMER.

    Description of Event or Problem · 1

    A COFLO FEEDING TUBE WAS PLACED AT THE BEDSIDE TOR ENTERAL NUTRITION. ACCORDING TO THE REPORTER IT HAD BEEN REPLACED AT LEAST ONCE DUE TO DISLODGEMENT. A FEW DAYS LATER THE PATIENT WENT TO THE OPERATING ROOM FOR ATTEMPTED PEG TUBE PLACEMENT. THE CORFLO TUBE WAS REMOVED WITHOUT DIFFICULTY. THE SURGEON WAS UNABLE TO FIND A SAFE WINDOW FOR PEG; THE PROCEDURE WAS ABORTED AND A NEW CORFLO TUBE WAS PLACED UNDER DIRECT VISUALIZATION WITH AN ENDOSCOPE. THE NEXT DAY THE PATIENT RETURNED TO OPERATING ROOM FOR A PLANNED GJ TUBE PLACEMENT. THE CORFLO TUBE WAS REMOVED. THE NEXT DAY THE PATIENT WAS NOTED TO HAVE RETAINED FOREIGN BODY ON X-RAY (LINEAR TUBING, UP TO 4.5CM, WEIGHTED TIP). FELT TO BE THE TIP OF THE CORFLO TUBE. FOLLOW UP X-RAY SHOWED PASSAGE THROUGH THE GI TRACT BUT UNCLEAR IF THE PATIENT PASSED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769970 CORFLO 8FR X 43 " ENTERAL FEEDING TUBE FEEDING TUBE KNT CORPAK MEDSYSTEMS 20-2438 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other