BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROMID

    MDR report key: 19776449 · Received July 18, 2024

    Report

    Report Number
    3015060232-2024-00015
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 18, 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 SHE WAS JUST PLACING A MIDLINE AND WAS NOT ABLE TO ADVANCE THE CATHETER PAST THE 6CM MARK. SHE PLACED THE GUIDEWIRE BACK IN THE MIDLINE, FELT SOME RESISTANCE, SAW A BULGE UNDER THE PATIENT'S SKIN AND REMOVED THE LINE. UPON REMOVAL, SHE IDENTIFIED THAT THE GUIDEWIRE HAD PUNCTURED THE CATHETER AND THE PATIENT EXPERIENCED A HEMATOMA, WHICH WAS ADDRESSED BY HOLDING PRESSURE TO THE SITE. THE COMPLAINANT DID NOT PROVIDE THE LOT NUMBER FOR THE CATHETER AND DID NOT RETURN THE CATHETER OR GUIDEWIRE FOR INVESTIGATION. BECAUSE THE CATHETER WAS NOT RETURNED FOR INVESTIGATION, THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE USER PIERCED THE CATHETER WITH THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467910 HYDROMID CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ACCESS VASCULAR. INC. MID-141 CM 00850030354211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other