BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL INC

    MDR report key: 317817 · Received February 23, 2001

    Report

    Report Number
    MW1021178
    Event Type
    Malfunction
    Date Received
    February 23, 2001
    Date of Event
    February 9, 2001
    Report Date
    February 23, 2001
    Manufacturer
    ARROW INT'L
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN CHECKING GUIDEWIRE PRIOR TO USE, A SIGNIFICANT RESISTANCE WAS NOTED WHICH PREVENTED THE CATHETER INSERTION. THIS RESISTANCE WAS NOTED IN 6 CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7188 ARROW INTERNATIONAL INC RADIAL ARTERY CATHETERIZATION SET DQO ARROW INT'L REF PRODUCT # RA-04020 9K4796

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other