BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI ONE BALLOON BUTTON

    MDR report key: 10337747 · Received July 29, 2020

    Report

    Report Number
    10337747
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 24, 2020
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MINI ONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE PLACED IN PATIENT. IN THE EVENING FOLLOWING SURGERY, PATIENT HAD AN EPISODE OF FORCEFUL COUGHING AND THE J-TUBE (FEEDING DEVICE) DISLODGED. THE PATIENT RETURNED TO THE OPERATING ROOM. PER THE OPERATIVE REPORT, THE J-TUBE MALFUNCTIONED, IT WAS NOTED THE JEJUNOSTOMY "BUTTON" HAD A HOLE IN IT, SO THE BALLOON WAS COLLAPSED. A NEW MINI ONE BALLOON BUTTON WAS PLACED. ON POD # 6, THERE WAS CONCERN OF A PROBLEM WITH THE NEW TUBE - FEEDINGS WERE NOTED TO BE LEAKING FROM THE NEW J-TUBE SITE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM. SURGEON NOTED THE MINI ONE BALLOON HAD MALFUNCTIONED - WHEN REMOVED, THE BALLOON ON THE TUBE WAS NOTED TO BE RUPTURED. BOTH TUBES WERE THE SAME LOT #, MODEL # & EXP DATE. MINI ONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE 14FR. X 3.5CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804453 MINI ONE BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1435 180405-361

    Patients

    Seq Age Sex Outcome Treatment
    1 6570 DA Other| R