BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.6FR PICC

    MDR report key: 23497119 · Received November 7, 2025

    Report

    Report Number
    MW5178611
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 1, 2025
    Manufacturer
    MEDCOMP / MEDICAL COMPONENTS INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN'S HAVE EXPERIENCED DIFFICULTY IN THE PAST 24 HOURS WITH FLUSHING AND WITHDRAWING BLOOD FROM THE RED LUMEN OF PATIENT'S 2.6FR PICC CATHETER. PT NOW COMPLAINING OF PAIN AT INSERTION SITE WHEN ATTEMPTS AT FLUSHING THE RED LUMEN OCCUR. BEDSIDE RN NOTIFIED ATTENDING MD AND RED LUMEN TO NO LONGER BE USED AT THIS TIME. IVT CONSULTED. IR CONSULT PLACED AND PLAN FOR PATIENT TO GET LINE RE-WIRED/REPLACED TOMORROW MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924759 2.6FR PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS MEDCOMP / MEDICAL COMPONENTS INC. MRXB830

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male