BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMT MINI ONE® EXTENSION SET

    MDR report key: 18282709 · Received December 7, 2023

    Report

    Report Number
    18282709
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 4, 2023
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    PIF
    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

    ENTERNAL EXTENSION SET (FOR G-TUBE) DISCOVERED TO HAVE CRACK AT THE Y-INSERTION SITE. THIS TUBING IS LESS THAN 48 HOURS OLD. ENFIT , PART # 8-1255-ISOSAF LOT # 230824-091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366168 AMT MINI ONE® EXTENSION SET GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF APPLIED MEDICAL TECHNOLOGY, INC. E8-1255-ISOSAF 230824-091

    Patients

    Seq Age Sex Outcome Treatment
    1 300 DA Male