BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 21777258 · Received April 4, 2025

    Report

    Report Number
    3015060232-2025-00011
    Event Type
    Malfunction
    Date Received
    April 4, 2025
    Date of Event
    March 6, 2025
    Report Date
    May 12, 2025
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    LJS
    UDI-DI
    00850030354334
    PMA / PMN Number
    K213550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 06 MAR 2025, THE COMPLAINANT REPORTED A HOLE IN A CATHETER. THE CATHETER WAS RETURNED TO THE MANUFACTURER AND THE BREAK WAS CONFIRMED. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED TO AVI ON (B)(6) 2025 AND EVALUATED ON (B)(6) 2025. AVI'S EVALUATION CONFIRMED DAMAGE TO THE CATHETER. THERE WAS INSUFFICIENT INFORMATION FROM THE USER TO CONFIRM THE CAUSE OF SUCH DAMAGE, THEREFORE NO ROOT CAUSE COULD BE ASSIGNED.

    Description of Event or Problem · 0

    REPORT OF A HOLE IN A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581944 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR. INC. PICC-251CM UNKNOWN 00850030354334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other