BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW SAC-00820-PBX

    MDR report key: 6928785 · Received October 9, 2017

    Report

    Report Number
    3006425876-2017-00454
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 15, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE ARTERIAL CATHETER WAS PLACED WITHOUT ANY COMPLICATION, AFTER 24 HOURS HEMODYNAMIC MONITORING WAS RATED BAD, AFTER 48 HOURS HEMODYNAMIC MONITORING WAS RATED VERY BAD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE ARTERIAL CATHETER WAS PLACED WITHOUT ANY COMPLICATION, AFTER 24 HOURS HEMODYNAMIC MONITORING WAS RATED BAD, AFTER 48 HOURS HEMODYNAMIC MONITORING WAS RATED VERY BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711078 ARROW SAC-00820-PBX CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71X16L0028

    Patients

    Seq Age Sex Outcome Treatment
    1