BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8335706 · Received February 13, 2019

    Report

    Report Number
    3006425876-2019-00094
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 22, 2019
    Report Date
    January 25, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: ON INSERTION OF A QUAD LUMEN CENTRAL LINE GUIDE WIRE THE DISTAL END WAS NOTED TO BE "KINKED". INSERTION HAD BEEN WITH A CANNULA INTO THE INTERNAL JUGULAR VEIN. IT WAS NOT POSSIBLE TO REMOVE THE CANNULA SHEATH DUE TO THE KINK.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (CATALOG# CV-22854-QE) IS NOT SOLD IN THE US. SIMILAR PRODUCT/COMPONENT SOLD IN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: ON INSERTION OF A QUAD LUMEN CENTRAL LINE GUIDE WIRE THE DISTAL END WAS NOTED TO BE "KINKED". INSERTION HAD BEEN WITH A CANNULA INTO THE INTERNAL JUGULAR VEIN. IT WAS NOT POSSIBLE TO REMOVE THE CANNULA SHEATH DUE TO THE KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129582 ARROW CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL INC. 71F18H2001

    Patients

    Seq Age Sex Outcome Treatment
    1