BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIONE BALLOON BUTTON

    MDR report key: 21796006 · Received April 8, 2025

    Report

    Report Number
    21796006
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 1, 2025
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING FIRST SET OF CARES, NURSE NOTICED BLEEDING AT THE G-TUBE [GASTRIC TUBE] SITE. THE SURROUNDING SKIN AND TISSUE LOOKED GOOD, AND THE BLEEDING WAS COMING FROM THE ACTUAL SITE OR HOLE. NURSE NOTIFIED THE PROVIDER, THE PROVIDER PUT IN AN ORDER FOR WOUND TEAM AND SURGERY TO CHECK IT OUT. UPON FURTHER INVESTIGATION, IT WAS FOUND THAT THE G-TUBE WAS NOT INFLATED WITH ANY WATER. UPON REPLACING WITH A NEW G-TUBE VIA SURGERY, IT WAS FOUND THAT THE PREVIOUS TUBE HAD A HOLE IN THE BALLOON, RESULTING IN THE G-TUBE BEING ABLE TO MOVE FREELY AND IRRITATE THE WALLS OF THE SITE, CAUSING THE BLEEDING. NEW G-TUBE WAS PLACED WITH FUNCTIONING BALLOON. MANUFACTURER RESPONSE FOR TUBES, GASTROINTESTINAL (AND ACCESSORIES), MINIONE BALLOON BUTTON (PER SITE REPORTER). APPLIED MEDICAL TECHNOLOGY PROVIDED A RETURN LABEL FOR THE SAMPLE SAVED FROM THIS INVESTIGATION. WE HAVE NOT RECEIVED INVESTIGATION RESULTS AS OF [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491694 MINIONE BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1412-I 241115-065

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male