BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE BALLOON BUTTON

    MDR report key: 24777061 · Received April 3, 2026

    Report

    Report Number
    1526012-2026-00007
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Report Date
    April 3, 2026
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071140793
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS A RESPONSE TO MEDSUN REPORT #(B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 02/13/2026. 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 REACHED OUT TO THE REPORTER TO GATHER ADDITIONAL INFORMATION REGARDING THE COMPLAINT AND TO SEE IF THE DEVICE IS AVAILABLE FOR RETURN. AT THE TIME OF THIS REPORT THERE HAS BEEN NO RESPONSE TO THE AVAILABILITY OF THE DEVICE. DUE TO THIS, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED, AND DEVICE FAILURE COULD NOT BE CONFIRMED. IF THE DEVICE IS RETURNED AT A LATER DATE, DEVICE EXAMINATION WILL NOT CHANGE THE NON-REPORTABILITY OF THIS COMPLAINT. BASED ON THE PROVIDED INFORMATION, THE REPORTED COMPLAINT IS NOT BELIEVED TO HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. NOTE, THE REPORTED LOT NUMBER, 260930-355, DOES NOT MATCH ANY PRODUCTION RECORDS. REVIEW OF PRODUCTION RECORDS FOUND THAT LOT NUMBER 250930-355 DOES MATCH A M1-5-1412-I MANUFACTURING LOT. IT IS BELIEVED THIS WAS THE INTENDED LOT TO BE REPORTED. A DEVICE HISTORY REVIEW WAS COMPLETED FOR LOT NUMBER 250930-355. NO ANOMALIES WERE FOUND AND THERE HAVE BEEN NO OTHER COMPLAINTS FROM THIS SAME BATCH. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. COMPLAINT #(B)(4) WAS ASSIGNED TO THIS REPORT FOR INTERNAL TRENDING.

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN MEDSUN REPORT #: (B)(4), IT WAS REPORTED THAT THE, "PATIENT WITH GASTROSTOMY TUBE (GT) BUTTON PLACED [REDACTED], BUTTON RUPTURED AND DISLODGED FROM PATIENT ON [REDACTED]-70 DAYS LATER. RN REPLACED WITH NEW GT BUTTON TUBE. NO HARM TO PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837709 MINIONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1412-I 250930-355 00842071140793

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male