BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW INTERNATIONAL, INC.

    MDR report key: 209590 · Received February 3, 1999

    Report

    Report Number
    MW1015665
    Event Type
    Malfunction
    Date Received
    February 3, 1999
    Date of Event
    January 25, 1999
    Report Date
    January 29, 1999
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLOOD NOTICED FROM LEFT WRIST ARTERIAL LINE SITE, DRESSING CHANGE ATTEMPTED BUT ARTERIAL CATHETER LEAKING INCREASED QUICKLY AND DID NOT STOP WHEN MANUAL PRESSURE APPLIED TO SITE. LINE REMOVED. UPON EXAM OF CATHETER, WHEN CATHETER WAS FLUSHED, IT FLUSHED OUT OF THE HUB, NOT THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL, INC. ARTERIAL LINE DQO ARROW INTL., INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other