BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RYMED IN VISION-PLUS

    MDR report key: 23512075 · Received November 10, 2025

    Report

    Report Number
    MW5178704
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    November 4, 2025
    Report Date
    November 6, 2025
    Manufacturer
    RYMED TECHNOLOGIES, LLC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RYMED IN VISION PLUS NEEDLESS CONNECTOR SET REF RYM-5001CL, LOT C00425, EXP. 2026-03-01; PART OF THE CONNECTOR BROKE OFF (ALMOST LIKE MELTED) DURING PATIENT USE. THIS WAS NOTED WHEN THE RN DISCONNECTED THE SALINE FLUSH FROM THE IV CONNECTOR. A STUCK ON FEELING MADE THE NURSE LOOK CLOSER OF THE CONNECTION. (SPECIFICALLY THE GREEN PART COVERING THE TIP OF THE LURE LOCK). WE HAVE PICTURES IF DESIRED OF PRODUCT AND DAMAGED CONNECTOR IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934545 RYMED IN VISION-PLUS SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC. RYM-5001CL C00425

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male