BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CATHETER KIT

    MDR report key: 8359138 · Received February 19, 2019

    Report

    Report Number
    MW5084185
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 31, 2019
    Report Date
    February 1, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR INTRACEREBRAL HEMORRHAGE, SUBARACHNOID HEMORRHAGE AND HELLP SYNDROME, (B)(6) PREGNANT REQUIRED EMERGENT C SECTION SURGERY. REQUIRED INVASIVE HYDRODYNAMIC MONITORING. ON (B)(6) 2019 STAFF WAS ABOUT TO CHANGE THE DRESSING ON THE ARTERIAL LINE WHEN IT WAS IDENTIFIED THAT THE ARTERIAL CATHETER HAD BEEN BROKEN OFF WITH ABOUT 1 CM OF CANNULA REMAINING PAST THE HUB. THE PHYSICIAN WAS NOTIFIED AND PERFORMED A BEDSIDE ULTRASOUND TO CONFIRM IF A PART OF THE CATHETER WAS REMAINING INSIDE THE PATIENT'S ARTERY. INTERVENTIONAL RADIOLOGY WAS CONTACTED, THE PATIENT WAS TRANSPORTED TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT, REQUIRING AN ADDITIONAL PROCEDURE TO IDENTIFY THE LOCATION OF REMAINING CATHETER WITHIN THE PATIENT¿S BODY AND SUBSEQUENT REMOVAL OF THE ARTERIAL CATHETER. ANOTHER SIMILAR EVENT WAS REPORTED WITHOUT PATIENT HARM, A PHYSICIAN HAD THE ABILITY TO REMOVE THE RETAINED PART OF THE CATHETER AT THE BEDSIDE. DATES OF USE: (B)(6) 2019. INTRACEREBRAL HEMORRHAGE, SUBARACHNOID HEMORRHAGE, PREECLAMPSIA/ECLAMPSIA AND HELLP SYNDROME; 880.5200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143316 ARTERIAL CATHETER KIT GAUZE/SPONGE INTERNAL, X-RAY DETECTABLE GDY ARGON MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention