BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINIONE EXTENSION SET

    MDR report key: 21699693 · Received March 26, 2025

    Report

    Report Number
    1526012-2025-00004
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 26, 2025
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    PIF
    UDI-DI
    00842071132446
    PMA / PMN Number
    K142989
    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 03/11/2025. THE OCCURRENCE WAS ORIGINALLY REPORTED TO AMT ON 02/10/2025 BY THE SAME INITIAL REPORTER. 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 ORIGINAL REPORTER TO OBTAIN THE DEVICE FOR EXAMINATION AND PERFORMED AN INSPECTION OF THE DEVICE ONCE RETURNED. EXAMINATION OF THE DEVICE WAS ABLE TO CONFIRM THE REPORTED COMPLAINT THAT THE ADAPTER CRACKED. THE REPORTED LOT NUMBER: 241418-004, DOES NOT EXIST. A REVIEW OF DEVICE LOTS AND SALES ORDERS FOUND THAT LOT: 241218-004 WAS MOST LIKELY THE LOT THAT WAS SUPPOSED TO BE REPORTED WITH THE DEVICE FAILURE. A DHR REVIEW FOUND THAT NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THE SAME MANUFACTURING 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. INFORMATION REGARDING DEVICE INVESTIGATION CAN BE FOUND UNDER COMPLAINT#: (B)(4).

    Description of Event or Problem · 0

    PER THE ORIGINAL REPORTER IN UF#: (B)(4), IT WAS REPORTED THAT, "AT THE HUB WHERE YOU SCREW SYRINGES INTO FOR A G-TUBE AND MIDDLE PIECE HAD BROKEN OFF AND WAS MISSING NOT ALLOWING THE COVER TO SECURE TO TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001115 AMT MINIONE EXTENSION SET ENTERAL EXTENSION SET PIF APPLIED MEDICAL TECHNOLOGY, INC. 8-1255-ISOSAF 241218-004 00842071132446

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male