BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS JUNIOR NEEDLESS IV CONNECTOR

    MDR report key: 19891918 · Received August 2, 2024

    Report

    Report Number
    19891918
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    January 28, 2024
    Report Date
    May 28, 2024
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INVISION-PLUS JUNIOR NEEDLELESS IV CONNECTOR WAS FOUND CHIPPED BY THE HUB OF PICC LINE CAUSING A LEAK. WHEN REPLACING THE INVISION-PLUS JUNIOR NEEDLELESS IV CONNECTOR, IT WAS NOTED A PIECE WAS LODGED INTO THE HUB OF THE PICC LINE. PICC LINE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958749 INVISION-PLUS JUNIOR NEEDLESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-8001CL

    Patients

    Seq Age Sex Outcome Treatment
    1 17 DA Male