BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 24946313 · Received April 21, 2026

    Report

    Report Number
    3021570645-2026-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 21, 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

    PICC-142CM INSTALLED ON (B)(6) 2026. PATIENT REPORTED PAIN, REDNESS (B)(6) 2026. CATHETTER COULD NOT BE FLSUHED OR ASPIRATED. CATHETER REMOVED THAT DAY AND COULD NOT BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008491 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR, INC. PICC-142CM 07112505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention