BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE BALLOON BUTTON

    MDR report key: 24620898 · Received March 17, 2026

    Report

    Report Number
    1526012-2026-00003
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Report Date
    March 17, 2026
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071140397
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO MEDWATCH REPORTS MW5182620, MW5182621, MW182622, AND MW5182623 WHICH WAS RECEIVED BY AMT FROM THE FDA ON 02/17/2026. THE OCCURRENCE WAS ORIGINALLY REPORTED TO AMT ON 01/16/2026 BY THE SAME INITIAL REPORTER. AN UPFRONT DEVICE REPLACEMENT WAS ISSUED TO THE CUSTOMER AS SOON AS THE PRESCRIPTION WAS RECEIVED. REVIEW OF TRACKING INFORMATION FOR THIS REPLACEMENT CONFIRMED IT WAS DELIVERED TO THE CUSTOMER'S RESIDENCE ON (B)(6). BASED ON THE PROVIDED INFORMATION, THE COMPLAINT IS NOT A REPORTABLE EVENT PER 21 CFR SECTION 803. THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT OR NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. AMT WORKED WITH THE ORIGINAL REPORTER TO OBTAIN THE DEVICES FOR EXAMINATION AND PERFORMED AN INSPECTION OF THE DEVICES ONCE RETURNED. EXAMINATION OF THE TWO RETURNED DEVICES WAS ABLE TO CONFIRM THE REPORTED COMPLAINT THAT THE INTERLOCKS HAD CRACKED. RECENT TRENDING DATA SHOWS NO ANOMALIES IN REPORTED FAILURES FROM THE FIELD. A DEVICE HISTORY REVIEW WAS COMPLETED FOR THE REPORTED LOT NUMBER, AND NO ANOMALIES WERE FOUND AND THERE HAVE BEEN NO OTHER COMPLAINTS FOR THESE SAME BATCHES. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. INFORMATION REGARDING DEVICE INVESTIGATION CAN BE FOUND UNDER COMPLAINTS #(B)(4) & (B)(4).

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN MEDWATCH REPORT #S: MW182620, MW182621, MW182622, AND MW182623, IT WAS REPORTED THAT, "MY 2.5YO SON'S GTUBE BUTTON (MINIONE REF M1-1215-I FROM APPLIED MEDICAL TECHNOLOGY INC.) HAS BROKEN AND CEASED WORKING ON FOUR OCCASIONS IN THE PAST TWO WEEKS DESPITE NORMAL USE. WE HAVE DEPLETED OUR SUPPLIES REPLACING THESE BUTTONS, WHICH ARE LASTING ABOUT 72 HOURS ON AVERAGE BEFORE BREAKING. THE SAME PATTERN REPEATS: THE INNER RING CRACKS AND THEN PREVENTS THE EXTENSION CONNECTOR FROM LOCKING INTO PLACE SO WE CANNOT DELIVER EITHER HIS FOOD OR MEDICATIONS. MY SON REQUIRES 24HR GTUBE ACCESS TO PREVENT HYPERAMMONEMIA, WHICH MAY CAUSE PERMANENT NEUROLOGICAL DAMAGE, COMA, AND DEATH. THERE IS NO COMMON LOT NUMBER, MANUFACTURING DATE, OR SUPPLIER SOURCE ACROSS ALL FOUR BROKEN BUTTONS, AND OTHER FAMILIES HAVE REPORTED IN MEDICAL FACEBOOK GROUPS THE SAME FAILURE IN OTHER PARTS OF THE COUNTRY, SUGGESTING THERE MIGHT BE A WIDESPREAD MANUFACTURING DEFECT. I HAVE CONTACTED AMT TO REPORT THE ISSUE AND REQUEST REPLACEMENT SUPPLIES, WHICH THEY INDICATED THEY WILL DO AT THE END OF A 2-4 WEEK INVESTIGATION AND TO UTILIZE THE ED FOR RESUPPLY IN THE INTERIM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682811 MINIONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1215-I 250922-318 00842071140397

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male