BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 19116128 · Received April 16, 2024

    Report

    Report Number
    3015060232-2024-00007
    Event Type
    Injury
    Date Received
    April 16, 2024
    Report Date
    April 16, 2024
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    FOZ
    UDI-DI
    00850030354211
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED THAT THE MIDLINE CATHETER HAD KINKED AND THAT WHEN IT WAS REMOVED A HOLE IN THE CATHETER WAS IDENTIFIED. THE COMPLAINANT PROVIDED AN IMAGE SHOWING THE HOLE. AVI HAS REQUESTED THAT THE CATHETER BE RETURNED FOR INVESTIGATION, BUT THE CATHETER HAS NOT BEEN RETURNED AND THE LOT NUMBER HAS NOT BEEN REPORTED. NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 0

    REPORT OF BREAK IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694892 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR INC. MID-141CM 00850030354211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other