BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE® BALLOON BUTTON

    MDR report key: 12915164 · Received December 2, 2021

    Report

    Report Number
    12915164
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 17, 2021
    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

    THE INTERNAL RETENTION BALLOON OF THE 14FR X 1.0CM MINIONE BALLOON BUTTON LOW PROFILE FEEDING DEVICE LEAKED CAUSING THE GASTROSTOMY TUBE TO BE DISLODGED FROM THE PATIENT. PATIENT'S MOTHER REPORTED THIS AS THE SECOND TIME THIS HAS HAPPENED, A SIMILAR SITUATION OCCURRED TWO WEEKS PRIOR WHERE THE TUBE CAME OUT AND THE BALLOON WAS NOT INTACT. WHEN TRYING TO INFLATE THE TUBE THERE WAS OBVIOUS LEAKAGE NOTED (LOT 210715-116, EXPIRATION DATE 2024-06-01, REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813645 MINI ONE® BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1410-I 210715-116

    Patients

    Seq Age Sex Outcome Treatment
    1 150 DA Male