BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RYMED

    MDR report key: 10585924 · Received September 25, 2020

    Report

    Report Number
    10585924
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 31, 2020
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RYMED INVISION CONNECTOR RING CAME OFF WHEN RN ATTACHED LUER SYRINGE. CAP REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051022 RYMED SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC M01981

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA