BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT

    MDR report key: 18066011 · Received November 2, 2023

    Report

    Report Number
    MW5147731
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 18, 2023
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A GJ FEEDING TUBE BY AVANOS HAD A FAULTY BALLOON THAT REQUIRED REPLACEMENT. THIS HAS HAPPENED THREE TIMES NOW. THE GJ TUBE HAD BEEN IN PLACE 1 WEEK, 1 MONTH, AND 2 WEEKS RESPECTIVELY. THE REF NUMBER OF THE PART IS: 8270-14-1.0-22. WE HAVE KEPT THE BOXES OF THE LAST TWO AND BOTH WERE MANUFACTURED ON 2023-07-12 AND HAD A LOT NUMBER OF 30268249. ALL CARE INSTRUCTIONS WERE FOLLOWED, AND EACH TIME THE BALLOON SPONTANEOUSLY FAILED. THIS HAS LED TO FLUID LOSS, SKIN IRRITATION, AN INABILITY TO CONTINUE DAILY ACTIVITIES, AND A RETURN TRIP TO INTERVENTIONAL RADIOLOGY TO REPLACE THE TUBE. THIS PIECE OF EQUIPMENT IS SUPPOSED TO LAST A MINIMUM OF 6 MONTHS. PLEASE ISSUE A RECALL AS THIS EFFECTS THE ABILITY OF PEOPLE USING THE PRODUCT TO RECEIVE NUTRITION, HYDRATION, AND MEDICATION. REFERENCE REPORTS MW5147730, MW5147732.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341210 MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 30268249

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female