BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC (MEDICAL INNOVATIONS CORP)

    MDR report key: 245049 · Received October 14, 1999

    Report

    Report Number
    MW1017337
    Event Type
    Injury
    Date Received
    October 14, 1999
    Date of Event
    October 13, 1999
    Report Date
    October 14, 1999
    Manufacturer
    BALLARD MEDICAL PRODUCTS
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRANSGASTRIC JEJUNAL TUBE PLACED ON 10/8 UNDER FLUOROSCOPY. EVENING OF 10/9 CHILD DEVELOPED SEVERE ABDOMINAL PAIN. DIAGNOSED AS PANCREATITIS. ON 10/13, BALLOON SECTION OF TUBE WAS NOTED TO BE AT THE EXTERNAL STOMA. TUBE READVANCED AND CHECKED FOR RESIDUAL FLUID. GASTRIC FLUID WAS WITHDRAWN FROM THE BALLOON FILL PORT. BALLOON GENLTY FLUSHED WITH STERILE WATER. GASTRIC FLUID AGAIN RETURNED THROUGH PORT. MD'S OFFICE NOTIFIED. LINE SECURED. FLUOROSCOPY ARRANGED FOR REPLACEMENT 10/14. UNABLE TO ADVANCE NEW TUBE ON 10/14 DUE TO PANCREATITIS. CLAIMS DEPT AT BALLARD NOTIFIED 10/13. UPON REMOVAL OF TUBE, BALLOON WAS NOTED TO BE RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC (MEDICAL INNOVATIONS CORP) Implant TRANSGASTRIC JEJUNAL FEEDING KIT KNT BALLARD MEDICAL PRODUCTS * 75934

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention ATTEMPTS TO ADVANCE REPLACEMENT TUBE SCHEDULED| ON 10/18/1999