BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROPICC

    MDR report key: 22100447 · Received May 28, 2025

    Report

    Report Number
    3015060232-2025-00014
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 28, 2025
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    LJS
    UDI-DI
    00850030354303
    PMA / PMN Number
    K213550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED KINKS AND A LEAK IN A SINGLE-LUMEN PICC. THE CATHETER WAS RETURNED TO AVI FOR EVALUATION AND THE CAUSE OF THE LEAK WAS A CLEAN, PERPENDICULAR OPENING AT THE 4.2CM MARK. THERE WERE NO SIGNS OF KINKING AT THE SITE OF THE OPENING. THE TYPE OF SECUREMENT DEVICE USED IS UNKNOWN. THE CAUSE OF THE OPENING COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    REPORT OF A HOLE IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433113 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR. INC. PICC-251CM 03072517 00850030354303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other