BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 20294377 · Received September 24, 2024

    Report

    Report Number
    3015060232-2024-00019
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 24, 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 SEVERAL HOURS AFTER INSERTION. THE LINE WAS NOT FLUSHING. DURING THE SECOND ATTEMPT TO FLUSH THE LINE WITH A SYRINGE, THE USER FELT THAT THE LINE HAD RUPTURED. THE USER REMOVED THE CATHETER AND SAW THE BREAK IN THE LINE AT THE 4.5CM MARK. THE LINE WAS RETURNED TO AVI FOR EVALUATION. THE MATERIAL AROUND THE BREAK AT THE 4.5CM MARK APPEARED STRETCHED AND WAS PERFORATED AXIALLY. IN ADDITION TO THE BREAK, THERE WAS EVIDENCE OF A KINK AT THE 5.6CM MARK. THE LINE WAS FLUSHED INDICATING THAT THERE WERE NO OCCLUSIONS IN THE LINE. THERE IS NO EVIDENCE SUGGESTING A STRUCTURAL OR MANUFACTURING DEFECT. THE CATHETER IS DESIGNED FOR USE WITH POWER INJECTION SYSTEMS WHILE PATENT. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE KINK OR THE BREAK.

    Description of Event or Problem · 0

    REPORT OF A RUPTURE IN A MIDLINE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016153 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR. INC. MID-141 CM 04242401 00850030354358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other