BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 22815628 · Received August 15, 2025

    Report

    Report Number
    3015060232-2025-00020
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Report Date
    August 8, 2025
    Manufacturer
    ACCESS VASCULAR, INC.
    Product Code
    LJS
    UDI-DI
    00850030354372
    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

    Additional Manufacturer Narrative · 0

    COMPLAINANT REPORTED THERE WAS A "RUPTURE" IN THE LINE. PRODUCT WAS NOT RETURNED FOR REVIEW AND PATIENT CONDITION AT DEVICE REMOVAL WAS NOT DESCRIBED.

    Description of Event or Problem · 0

    REPORT OF A HOLE IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2704184 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM OVER 30 DAYS LJS ACCESS VASCULAR, INC. PICC-142CM 02282504 00850030354372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other