BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE TRIPLE LUMEN 20CM CVC KIT

    MDR report key: 23597832 · Received November 19, 2025

    Report

    Report Number
    MW5179076
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    September 27, 2025
    Report Date
    November 14, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OFF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CENTRAL VENOUS CATHETER UNABLE TO BE FED OVER THE PROVIDED GUIDEWIRE, RESULTING IN ADDITIONAL PUNCTURES TO THE PATIENT FROM OBTAINING NEW/ADDITIONAL SUPPLIES OUTSIDE OF THE PROVIDED KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023822 MEDLINE TRIPLE LUMEN 20CM CVC KIT CENTRAL VENOUS CATHETER TRAY OFF MEDLINE INDUSTRIES, LP - SPT STCVC2040B 2025042190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CENTRAL VENOUS BUNDLE 3 LUMEN.