BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 25037708 · Received April 29, 2026

    Report

    Report Number
    3021570645-2026-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 30, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    PMA / PMN Number
    K243941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED PAIN, REDNESS AND SWELLING. THE CATHETER COULD NOT BE ASPIRATED OR FLUSHED. CATHETER REMOVED BY HEALTHCARE PROFESSIONAL. CLOT FOUND IN DISTAL END OF THE CATHETER; THE CATHETER WAS ALSO LEAKING FROM A HOLE JUST PROXIMAL TO THE CLOT. USER ALSO OBSERVED THAT THE RADIOPACITY OF THE CATHETER WAS NOT STRONG ENOUGH TO BE ADEQUATELY VISUALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418756 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR, INC. PICC-142CM 08272503

    Patients

    Seq Age Sex Outcome Treatment
    1