BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW 2 LUMEN BLUE HIGH VOLUME WITH BLUE FLEXTIP

    MDR report key: 22211364 · Received June 16, 2025

    Report

    Report Number
    22211364
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    April 29, 2025
    Report Date
    June 6, 2025
    Manufacturer
    TELEFLEX MEDICAL LLC
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    HD [HEMODIALYSIS] CATHETER WHITE SECUREMENT DEVICE WAS SUTURED TO PATIENT¿S SKIN; CATHETER CAME OUT OF SECUREMENT DEVICE AND OUT OF PATIENT. THE SUTURES WERE PLACED AT THE TRIANGULAR JUNCTURE HUB WITH INTEGRAL ROTATING SUTURE WINGS, AND THE BLUE PLASTIC PIECE WAS ABLE TO SLIP OUT OF THAT. THIS SAME EXACT ISSUE OCCURRED WITH 2 DIFFERENT PATIENT¿S AND THE LINES WERE PLACED BY TWO DIFFERENT PROVIDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683036 ARROW 2 LUMEN BLUE HIGH VOLUME WITH BLUE FLEXTIP CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB TELEFLEX MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female Other