BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7FR X 20CM

    MDR report key: 11711258 · Received April 22, 2021

    Report

    Report Number
    3006425876-2021-00345
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON INSERTION THE INTRODUCER NEEDLE BROKE RIGHT NEXT TO THE CONNECTION AT THE RAULERSON SYRINGE. A SECOND SET WAS OPENED AND THE SAME THING HAPPENED, BUT THIS TIME LEAVING THE NEEDLE INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE NEEDLE WITH AN ARTERY CLAMP. A THIRD SET WAS OPENED, THIS TIME A MULTI LUMEN WHICH WAS INSERTED SUCCESSFULLY. X-RAY WAS PERFORMED TO CHECK FOR POSSIBLE PNEUMOTHORAX. THE PATIENT WAS REPORTED TO BE FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON INSERTION THE INTRODUCER NEEDLE BROKE RIGHT NEXT TO THE CONNECTION AT THE RAULERSON SYRINGE. A SECOND SET WAS OPENED AND THE SAME THING HAPPENED, BUT THIS TIME LEAVING THE NEEDLE INSIDE THE PATIENT. THE PHYSICIAN REMOVED THE NEEDLE WITH AN ARTERY CLAMP. A THIRD SET WAS OPENED, THIS TIME A MULTI LUMEN WHICH WAS INSERTED SUCCESSFULLY. X-RAY WAS PERFORMED TO CHECK FOR POSSIBLE PNEUMOTHORAX. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602602 ARROW CVC SET: 2-LUMEN 7FR X 20CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F20D1853

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention