BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROVIAC 5FR DOUBLE LUMEN

    MDR report key: 21994818 · Received May 9, 2025

    Report

    Report Number
    MW5170180
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 2, 2025
    Manufacturer
    MEDICAL COMPONENTS INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    POSSIBLE BROKEN BROVIAC LINE A 5FR DOUBLE LUMEN PLACED VIA THE LEFT INTERNAL JUGULAR @ 27.5CM. LOT#MRPA120 CT COMPATIBLE LINE BEING REPLACED WAS 5FR DUAL LUMEN. P THE WHITE LUMEN WAS RUNNING HEPARIN 200 UNITS/ML IN DEXTROSE 5% IN WATER + MILRINONE 600 MCG/ML IN D5W AND THE PURPLE/POWERPORT LUMEN WAS RUNNING TREPROSTINIL 10,000 NG/ML IN NORMAL SALINE (NEVER IDENTIFIED ANY OTHER MEDICATION ADMINISTRATION TO THIS LUMEN) DURING THIS TIME FRAME. THERE WERE A FEW OTHER IV MEDICATIONS ADMINISTERED DURING THIS TIME: O LORAZEPAM IV X1 DOSE ON 4/8 (2 MG/ML VIAL) O MIDAZOLAM INTRAVENOUS PRO RE NATA DRESSING CHANGES ON 4/8, 4/10, AND 4/17 (5 MG/ML 2 ML VIAL) O ONDANSETRON IV ON 4/7 AND 4/9 (4 MG/2 ML VIAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182083 BROVIAC 5FR DOUBLE LUMEN CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS INC MRPA120

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention