BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROMID

    MDR report key: 22512577 · Received July 15, 2025

    Report

    Report Number
    3015060232-2025-00019
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    FOZ
    UDI-DI
    00850030354358
    PMA / PMN Number
    K220772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18 JUN 2025, AVI WAS MADE AWARE OF A LEAK IN A MIDLINE CATHETER. THE CATHETER WAS RETURNED TO AVI ON 02 JULY 2025 WITH ADDITIONAL INFORMATION THAT THE MIDLINE HAD BEEN IN PLACE FOR 40 DAYS AND THAT THE LINE WAS LEAKING INTERMITTENTLY FROM THE EXTERNAL PORTION OF THE CATHETER. AVI COMPLETED THE EVALUATION OF THE CATHETER AND CONFIRMED A BREAK IN THE EXTERNAL PORTION OF THE CATHETER AT THE SUTURE WING TIP. THE LINE WAS REPLACED. NO CLINICAL IMPACT TO THE PATIENT WAS REPORTED. NO ROOT CAUSE OF THE BREAK COULD BE DETERMINED.

    Description of Event or Problem · 0

    REPORT OF A BREAK IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160160 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR. INC. MID-141CM 02192506 00850030354358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other