BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5FR X 16CM

    MDR report key: 10676804 · Received October 14, 2020

    Report

    Report Number
    3006425876-2020-00869
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 22, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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

    CUSTOMER REPORTED "WHEN A LUMEN OF THE CVC HAD BEEN USED TO INFUSE GTN THROUGH, THAT AFTER ASPIRATING AND FLUSHING WITH NORMAL SALINE, THAT A SHORT TIME OR EVEN HOURS AFTER, IF THAT LINE WAS USED AGAIN, THE PATIENT WOULD HAVE A DROP IN BLOOD PRESSURE AS THOUGH THEY ARE GIVING A DOSE OF GTN." THE PATIENT'S CONDITION IS REPORTED AS FINE. NO REPORT OF AN INJURY OR A REQUIRED INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED "WHEN A LUMEN OF THE CVC HAD BEEN USED TO INFUSE GTN THROUGH, THAT AFTER ASPIRATING AND FLUSHING WITH NORMAL SALINE, THAT A SHORT TIME OR EVEN HOURS AFTER, IF THAT LINE WAS USED AGAIN, THE PATIENT WOULD HAVE A DROP IN BLOOD PRESSURE AS THOUGH THEY ARE GIVING A DOSE OF GTN." THE PATIENT'S CONDITION IS REPORTED AS FINE. NO REPORT OF AN INJURY OR A REQUIRED INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140396 ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F19F1616

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.| NONE REPORTED.