BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO

    MDR report key: 5161391 · Received October 20, 2015

    Report

    Report Number
    5161391
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    August 4, 2015
    Report Date
    September 22, 2015
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH DYSPHAGIA HAD A CORFLO FEEDING TUBE PLACED AT BEDSIDE FOR ENTERAL NUTRITION; REPORTEDLY 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 (TIP NOT INSPECTED BUT SLID OUT EASILY). THE SURGEON WAS UNABLE TO FIND A SAFE WINDOW FOR PEG; THE PROCEDURE WAS ABORTED AND A NEW CORFLO TUBE PLACED UNDER DIRECT VISUALIZATION WITH ENDOSCOPE. THE NEXT DAY, THE PATIENT RETURNED TO OPERATING ROOM FOR PLANED GJ TUBE. CORFLO TUBE REMOVED (TIP NOT INSPECTED, NOT ISSUES WITH REMOVAL REPORTED). GJ TUBE PLACED SUCCESSFULLY. THE FOLLOWING DAY, THE PATIENT NOTED TO HAVE RETAINED FOREIGN BODY ON X-RAY (LINEAR TUBING, UP TO 4.5 CM, WEIGHTED TIP). FELT TO BE THE TIP OF A CORFLO TUBE. SERIAL X-RAY SHOWED PASSAGE THROUGH GI TRACT BUT UNCLEAR IF THE PATIENT HAS EVER EXPELLED THE OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691536 CORFLO TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CORPAK MEDSYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR