BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE® BALLOON BUTTON

    MDR report key: 20135960 · Received September 4, 2024

    Report

    Report Number
    1526012-2024-00010
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    June 1, 2024
    Report Date
    September 26, 2024
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071113810
    PMA / PMN Number
    K945618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 08/08/2024. WITHIN THIS REPORT, IT WAS NOTED THAT THIS WAS THE SECOND INCIDENT OF A DEVICE FAILURE OF THIS NATURE FOR THE PATIENT. TWO OCCURRENCES WERE ORIGINALLY REPORTED TO AMT ON 07/08/2024 BY THE SAME INITIAL REPORTER, AND ONE DEVICE WAS RETURNED FOR EVALUATION. IT WAS REPORTED THAT THESE DEVICES WERE IN USE FOR 14-15 DAYS, WHILE THE INFORMATION MARKED IN THE MEDSUN REPORT STATED THE DEVICE WAS IN USE FOR 1 DAY. FOR REPORTING PURPOSES, THE DEVICE LIFE OF 1 DAY, OCCURRENCE DATE OF JUNE 2024, AND AWARENESS DATE OF 08/08/2024 WERE REPORTED IN THIS FORM. ON ALL ACCOUNTS, IT WAS REPORTED THAT THE DEVICE WAS REPLACED, AND THAT NO PATIENT INJURY OCCURRED. IT IS BELIEVED THAT THE DEVICE RETURNED TO AMT ON 07/15/2024 IS THE SAME DEVICE REFERENCED IN THE MEDSUN REPORT. 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 DEVICE FOR EXAMINATION AND PERFORMED AN INSPECTION OF THE DEVICE ONCE RETURNED. A TEAR IN THE BALLOON WALL WAS IDENTIFIED ON THE RETURNED DEVICE. A DEVICE HISTORY REVIEW WAS COMPLETED FOR THE DEVICE LOT NUMBER AND NO ANOMALIES WERE FOUND AND THERE HAVE BEEN NO OTHER COMPLAINTS FROM OTHER USERS REGARDING BALLOON TEARS OR RUPTURES FROM THIS SAME BATCH. RECENT TRENDING DATA SHOWS NO ANOMALIES IN REPORTED FAILURES FROM THE FIELD. THE COMPLAINT INFORMATION HAS BEEN LOGGED INTO OUR COMPLAINT DATABASE FOR TRENDING PURPOSES. REPORTING INFORMATION CAN BE FOUND UNDER COMPLAINT # (B)(4). INFORMATION REGARDING DEVICE INVESTIGATION CAN BE FOUND UNDER COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A, "12 FR GT BALLOON DAMAGED AND LEAKING. SURGICAL TEAM TO BEDSIDE AND REPLACED GASTRONOMY TUBE (GT). FOLLOW-UP IMAGING REQUIRING TRANSPORTING PATIENT TO X-RAY FOR IMAGING STUDIES NEEDED. G-T SAVED IN BIOHAZARD BAG AND PLACED IN DEFECTIVE PRODUCT BIN. THIS IS THE SECOND INCIDENCE OF SOMETHING LIKE THIS HAPPENING FOR THIS PATIENT'S GT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848342 MINI ONE® BALLOON BUTTON LOW PROFILE GASTROSTOMY FEEDING TUBE KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1208-I 230317-445 00842071113810

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female