BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORFLO-ULTRA

    MDR report key: 1685618 · Received May 5, 2010

    Report

    Report Number
    1419949-2010-00004
    Event Type
    Other
    Date Received
    May 5, 2010
    Date of Event
    April 3, 2010
    Report Date
    May 4, 2010
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    FPD
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORT FROM THE CUSTOMER AND THE EVAL OF THE RETURNED SAMPLE, IT APPEARS THE FEEDING TUBE BECAME OCCLUDED. SINCE IT HAD BEEN USED FOR SOME PERIOD OF TIME WITHOUT DIFFICULTY, IT WAS LIKELY OVER TIME THAT FEED AND/OR MEDICINE BUILT UP ON THE FEEDING TUBE. IT IS POSSIBLE THAT BECAUSE OF THE OCCLUSION, PRESSURE WAS ABLE TO BUILD UP IN THE TUBE AND CAUSE THE FEEDING TUBE MATERIAL TO BALLOON AND EVENTUALLY BREAK. THE IFU INSTRUCTS THE USER TO IRRIGATE THE TUBE ROUTINELY; IN ADDITION, THE IFU CONTAINS A WARNING "VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS OR UNBLOCK THE TUBE."

    Description of Event or Problem · 1

    EVENT DESC: NURSING STAFF NOTED PATENCY DIFFICULTIES WITH AN ENTERAL FEEDING TUBE SEVERAL DAYS AFTER INSERTION. A KUB (KIDNEY, URETER, BLADDER) FILM REVEALED A PIECE APPROX TWO INCHES LONG HAD SEPARATED. THE TUBE WAS REMOVED. THE CLINICIANS ARE WAITING FOR THE TWO INCH PIECE TO PASS THROUGH THE PT'S GI TRACT. (B)(6). ACCORDING TO THE FACILITY AS OF (B)(6) 2010, THE PT WAS RELEASED AND IT IS UNK WHETHER OR NOT THE REMAINING PORTION PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO-ULTRA TUBE, FEEDING FPD CORPAK MEDSYSTEMS NA 40458

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other