BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARROW INTERNATIONAL

    MDR report key: 473545 · Received July 16, 2003

    Report

    Report Number
    MW1029050
    Event Type
    Other
    Date Received
    July 16, 2003
    Date of Event
    July 2, 2003
    Report Date
    July 7, 2003
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTION OF ARTERIAL CATHETER GUIDE WIRE AND CATHETER WAS ADVANCED WITH GOOD FLASH BACK OF BLOOD. PHYSICIAN WAS REMOVING THE GUIDE WIRE IT STARTED TO UNRAVEL AND BROKE OFF. X-RAY CONFIRMED THAT A PIECE OF WIRE WAS INDEED IN PT'S WRIST (APPROX. 3MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL RADIAL ARTERY CATH. SET DQO ARROW INTERNATIONAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other