BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ARROWG+ARD BLUE PLUS

    MDR report key: 23509651 · Received November 10, 2025

    Report

    Report Number
    23509651
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    May 2, 2025
    Report Date
    September 16, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV THERAPIST ASSESSED A MALFUNCTIONING RIGHT DOUBLE LUMEN IJ [INTERNAL JUGULAR] PLACED ON THE PREVIOUS DAY. UPON FLUSH ASSESSMENT, BROWN LUMEN HAS EXTERNAL RUPTURE. NO PRODUCT NUMBER CHARTED THAT I COULD LOCATE BUT THE DEVICE IS AN ARROWG+ARD BLUE PLUS CDC-45802-XP1A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525387 ARROW ARROWG+ARD BLUE PLUS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ TELEFLEX MEDICAL LLC CDC-45802-XP1A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown