BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 24794 · Received July 28, 1995

    Report

    Report Number
    24794
    Event Type
    Injury
    Date Received
    July 28, 1995
    Date of Event
    March 6, 1995
    Report Date
    March 20, 1995
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT'S RADIAL ARTERIAL CATHETER WAS FOUND LEAKING AT THE CATHETER NEAR THE HUB. THE LINE HAD BEEN PLACED APPROX 12 HRS EARLIER. THE PT'S ARTERIAL LINE WAS DISCONTINUED. THIS IS THE 6TH KNOWN INCIDENT TO HAVE OCCURRED SINCE 11/94. SEE MEDWATCH REPORTS #34-0061-1994-0014, 34-0061-1995-0001, 34-0061-1995-0005, 34-006-1995-0006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL ARTERY CATHETERIZATION SET Implant ARTERY CATHETER DQO ARROW INTERNATIONAL, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention