BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC KIT: 24GA X 3-1/2" (9CM)

    MDR report key: 16352781 · Received February 10, 2023

    Report

    Report Number
    9680794-2023-00054
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 13, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K810962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: A MEASURED LINE CATHETER IS PASSED IN THE RIGHT ARM, AND AT THE MOMENT OF CHANNELING THE VEIN, A RETURN IS OBTAINED, THE GUIDE IS INSERTED, AND AT THE TIME OF WITHDRAWAL IT IS OBSERVED WITH RESISTANCE AND OBSERVING STRETCH OF THE METAL LINE DURING THE INTERVENTION. THE INTENSIVIST ON SHIFT IS INFORMED IMMEDIATELY, WHO TALKS TO THE FATHER. A THORAX X-RAY IS TAKEN WITH AN EXTENSION TO THE FOREARM, OBSERVING A SMALL METALLIC IMAGE IN THE RIGHT ARM. PERIPHERAL VASCULAR SURGERY ASSESSMENT AND CONTROL X-RAYS ARE REQUESTED. THE FATHER IS INFORMED OF THE EVENT AND MEASURES TO BE TAKEN, GUIDELINES AND CATHETER PACKAGING ARE SAVED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: A MEASURED LINE CATHETER IS PASSED IN THE RIGHT ARM, AND AT THE MOMENT OF CHANNELING THE VEIN, A RETURN IS OBTAINED, THE GUIDE IS INSERTED, AND AT THE TIME OF WITHDRAWAL IT IS OBSERVED WITH RESISTANCE AND OBSERVING STRETCH OF THE METAL LINE DURING THE INTERVENTION. THE INTENSIVIST ON SHIFT IS INFORMED IMMEDIATELY, WHO TALKS TO THE FATHER. A THORAX X-RAY IS TAKEN WITH AN EXTENSION TO THE FOREARM, OBSERVING A SMALL METALLIC IMAGE IN THE RIGHT ARM. PERIPHERAL VASCULAR SURGERY ASSESSMENT AND CONTROL X-RAYS ARE REQUESTED. THE FATHER IS INFORMED OF THE EVENT AND MEASURES TO BE TAKEN, GUIDELINES AND CATHETER PACKAGING ARE SAVED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162614 ARROW CVC KIT: 24GA X 3-1/2" (9CM) CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 13F22E0386

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other NOT REPORTED| NOT REPORTED