BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI ONE(R) BALLOON BUTTON

    MDR report key: 11697365 · Received April 20, 2021

    Report

    Report Number
    1526012-2021-00013
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 9, 2021
    Report Date
    April 20, 2021
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    UDI-DI
    00842071100025
    PMA / PMN Number
    K161413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A RESPONSE TO REPORT # (B)(4) WHICH WAS RECEIVED BY AMT FROM THE FDA ON 03/22/2021. BASED ON THE PROVIDED INFORMATION, THE INCIDENT 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 REPORTER AND OBTAINED THE DEVICE FOR EXAMINATION ON 3/24/2021. THE DEVICE WAS EXAMINED AND THERE WAS NO INDICATION THAT A MANUFACTURING DEFECT CAUSED THE FAILURE OF THE DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND FOR THE RELATED LOT. COMPLAINT # (B)(4) WAS ASSIGNED TO THIS REPORT. THE COMPLAINT HAS BEEN LOGGED AND WILL BE USED IN OUR COMPLAINT TRENDING PROCESS FOR FUTURE PRODUCT ENHANCEMENTS.

    Description of Event or Problem · 1

    PER THE INITIAL REPORTER'S ORIGINAL REPORT IN REPORT #: (B)(4), "G TUBE DISLODGED/REMOVED. INFANT WAS TRANSFERRED WITH A GASTROSTOMY TUBE (GT). BALLOON WAS FOUND TO HAVE A LEAK. 10FR SUCTION TUBE USED TO MAINTAIN PATENCY. BALLOON ON DEVICE FAILED. ON INSPECTION DEVICE BALLOON WILL NOT INFLATE A SMALL AMOUNT BUT BEYOND 0.5ML OF AIR EVERYTHING JUST LEAKS OUT. THIS DEVICE WAS PLACED BY AN OUTSIDE FACILITY SO NO LOT NUMBER INFORMATION IS AVAILABLE. MANUFACTURER HAS BEEN CONTACTED BY EMAIL. THERE WAS NO DETECTABLE HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589319 MINI ONE(R) BALLOON BUTTON TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC. M1-5-1212 190416-144 00842071100025

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO