BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL LINE TUBING

    MDR report key: 12040422 · Received June 21, 2021

    Report

    Report Number
    MW5102001
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    June 13, 2021
    Report Date
    June 16, 2021
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) WENT TO DO CL BUNDLE CHECK, PT'S CL CAPS HAS RESIDUAL BLOOD (RYMED CHG CAP), INFORMED RN THAT WILL HELP CHANGE NC, RIGHT AFTER CONNECT IV TUBING TO RYMED INVISION-PLUS (RYM-5001CL) NEEDLESS CONNECTOR CAP, CRACK FOUND IN THE RING OF THE IV TUBING RYM-5001CL IS CAUSING CRACKING ON THE ALARIS TUBING WHEN CONNECTED TO THE INFUSION SET. THE RYM-7001 WAS CAUSING BLOOD BACK UP IN THE IV CONNECTOR. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934185 CENTRAL LINE TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-7001 M02171
    934186 CENTRAL LINE TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-7001 M02161
    934187 CENTRAL LINE TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-7001 M02118
    934188 CENTRAL LINE TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-7001 M02134

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention