BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 19425062 · Received May 30, 2024

    Report

    Report Number
    3015060232-2024-00013
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    April 28, 2024
    Report Date
    May 30, 2024
    Manufacturer
    ACCESS VASCULAR. INC.
    Product Code
    FOZ
    PMA / PMN Number
    K203069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT REPORTED AN INCIDENT INVOLVING A MIDLINE CATHETER. THE CATHETER WAS INITIALLY DETECTED TO HAVE A LEAK, PROMPTING REPLACEMENT WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). FORTUNATELY, THERE WAS NO CLINICAL IMPACT ON THE PATIENT. THE MIDLINE CATHETER HAD BEEN IN PLACE FOR TWO DAYS. PLACEMENT OF THE CATHETER PROVED CHALLENGING DUE TO THE PATIENT'S LIMITED VESSEL OPTIONS AND THE DEPTH OF VESSELS. THE FULL 20CM CATHETER LENGTH WAS USED DURING INSERTION INTO THE BRACHIAL VEIN. WHILE THE CATHETER WAS IN PLACE, CATHFLO WAS INSTILLED, AND THE CATHETER WAS RETRACTED TO FACILITATE FLUSHING AND BLOOD RETURN. UPON REMOVAL, A BREAK IN THE CATHETER LINE WAS IDENTIFIED AT THE 10.5CM MARK, AND A KINK WAS OBSERVED AT THE 3CM MARK. FURTHER INVESTIGATION REVEALED ADDITIONAL KINKS AT THE 7CM AND 12CM MARKS. NOTABLY, THIS PATIENT PRESENTED THE MOST CHALLENGING CASE FOR OBTAINING VASCULAR ACCESS, NECESSITATING CATHETER TUNNELING. IT IS POSSIBLE THAT THE ADIPOSE TISSUE SHIFTING DURING TUNNELING CONTRIBUTED TO THE KINKING, ALTHOUGH NO DEFINITIVE ROOT CAUSE FOR THE BREAK OR KINKS WAS IDENTIFIED.

    Description of Event or Problem · 0

    REPORT OF A BREAK IN A MIDLINE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099043 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR. INC. MID-141 CM 01162411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other