BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROWG+ARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS FOR USE WITH 7.5-8

    MDR report key: 22052280 · Received May 20, 2025

    Report

    Report Number
    MW5170605
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 5, 2025
    Report Date
    May 15, 2025
    Manufacturer
    TELEFLEX LLC. (NADC 2)
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDE WIRE TIP FRAGMENT FOUND AFTER CENTRAL LINE PLACEMENT FAILURE. THIN LINEAR DENSITY MEASURING APPROXIMATELY 1.8 CM, PRESUMED GUIDEWIRE TIP, IS SEEN WITHIN THE RIGHT TRANSVERSE FORAMEN OF C6 EXTENDING TO THE RIGHT NEURAL FORAMINA OF C6-C7, POSSIBLY WITHIN THE RIGHT VERTEBRAL ARTERY VERSUS VERTEBRAL VENOUS PLEXUS. 2. ADDITIONAL PUNCTATE HYPERDENSITY IS NOTED IN THE SVC, POSSIBLY A GUIDEWIRE FRAGMENT. REF REPORT: MW5170606.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78428 ARROWG+ARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS FOR USE WITH 7.5-8 INTRODUCER, CATHETER DYB TELEFLEX LLC. (NADC 2) 33F24HH0331

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female