BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 4-LUMEN 8.5FR X 16CM

    MDR report key: 10241948 · Received July 7, 2020

    Report

    Report Number
    3006425876-2020-00585
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 26, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(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

    IT WAS REPORTED THAT THE DILATOR KINKED THE GUIDE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DILATOR KINKED THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704509 CVC SET: 4-LUMEN 8.5FR X 16CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. IPN030865 71F20D0155

    Patients

    Seq Age Sex Outcome Treatment
    1