BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 19722506 · Received July 11, 2024

    Report

    Report Number
    3015060232-2024-00014
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 15, 2024
    Report Date
    July 11, 2024
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    FOZ
    UDI-DI
    00850030354358
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED A BREAK IN A MIDLINE CATHETER AFTER POWER INJECTION WAS USED FOR A CT ANGIOGRAM. THE CATHETER HAD BEEN IN PLACE FOR THREE DAYS. THE PATIENT EXPERIENCED SWELLING AND PAIN IN THE ARM. THE CATHETER WAS RETURNED FOR INVESTIGATION. THE INVESTIGATION IDENTIFIED A BREAK AT THE 3.5CM MARK, INDICATIONS OF KINKS AT THE 4.5CM AND 15.2CM MARKS, AND AN OCCLUSION WITHIN THE CATHETER AT THE 19.5CM MARK. THERE WAS NO EVIDENCE SUGGESTING A STRUCTURAL OR MANUFACTURING DEFECT. THE ROOT CAUSE OF THE KINKS AND OCCLUSION COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    REPORT OF A BREAK IN A CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379835 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR. INC. MID-141CM 04242401 00850030354358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other