BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL ARTERY CATHETERIZATION SET

    MDR report key: 24783 · Received July 28, 1995

    Report

    Report Number
    24783
    Event Type
    Injury
    Date Received
    July 28, 1995
    Date of Event
    February 20, 1995
    Report Date
    February 27, 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 DEVELOPED A CRACK UNDER THE SKIN. THE CATHETER HAD BEEN PLACED ON 2/17/95. THE PT'S ARTERIAL LINE WAS DISCONTINUED. THIS IS THE 5TH KNOWN INCIDENT TO HAVE OCCURRED SINCE 11/23/94. SEE MEDWATCH REPORT #34-0061-1994-0014, 34-0061-1995-0001, & 34-0061-1995-0005.

    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 54 YR Required Intervention