BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTERIAL CATHETER

    MDR report key: 34530 · Received July 8, 1996

    Report

    Report Number
    34530
    Event Type
    Injury
    Date Received
    July 8, 1996
    Date of Event
    April 17, 1996
    Report Date
    April 25, 1996
    Manufacturer
    DLP, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER SEPARATED FROM HUB FOLLOWING INSERTION ALLOWING BLOOD LEAKAGE. THE FIRST TWO CATHETERS WERE NOT RETAINED. THERE WERE NO PERMANENT SEQUELAE AS A RESULT OF ANY OF THE INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATHETER ARTERIAL CATHETER DWF DLP, INC. 5FR X 24 IN 6951-1006

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention