BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN, DUAL LUMEN, APHERESIS

    MDR report key: 171710 · Received June 5, 1998

    Report

    Report Number
    171710
    Event Type
    Injury
    Date Received
    June 5, 1998
    Date of Event
    April 30, 1998
    Report Date
    May 1, 1998
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    4/30/98 1159 PM PT NOTED DRESSING OF HICKMAN WAS SATURATED. LINE SUTURED. RESISTANCE NOTED AND FLUID LEAKING OUT TUNNEL. WHEN LINE WAS DISCONTINUED; UPON EXAM A PIN HOLE WAS NOTED IN THE RED LUMEN (IN THE PART OF THE BODY OF CATHETER THAT WOULD BE EXPECTED TO BY LAYING IN THE TUNNEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN, DUAL LUMEN, APHERESIS Implant HICKMAN CATHETER (CENTRAL VENOUS CATHETER) DQO BARD ACCESS SYSTEM 13.5 FRENCH 36C1455

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention