BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 22286766 · Received June 18, 2025

    Report

    Report Number
    3015060232-2025-00016
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    May 20, 2025
    Report Date
    June 18, 2025
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    LJS
    PMA / PMN Number
    K220772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 20 MAY 2025, THE COMPLAINANT REPORTED A BREAK IN A SINGLE-LUMEN MIDLINE. THE LINE WAS DISCONTINUED AND REPLACED WITH A CENTRAL LINE. THE LINE WAS RETURNED TO AVI AND THE BREAK WAS CONFIRMED. THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED. THE ROOT CAUSE OF THE BREAK COULD NOT BE DETERMINED. THERE WAS NO REPORT OF PATIENT CONDITION.

    Description of Event or Problem · 0

    REPORT OF A HOLE IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747405 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR. INC. PICC-142CM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other