BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS

    MDR report key: 20682240 · Received November 14, 2024

    Report

    Report Number
    20682240
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    September 15, 2024
    Report Date
    October 17, 2024
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    KNT
    UDI-DI
    10817522011325
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A 60-INCH ENTERAL FEEDING EXTENSION SET WAS PRIMED FOR INFANT FEEDING AND FOUND TO HAVE A PINHOLE LEAK ON THE SIDE OF THE FEMALE CONNECTOR OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224313 AMERITUS TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT KENTEC MEDICAL, INC. OC-ENT-060 KS2403008 10817522011325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown