BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRAL VENOUS CATHETER

    MDR report key: 34367 · Received July 5, 1996

    Report

    Report Number
    34367
    Event Type
    Injury
    Date Received
    July 5, 1996
    Date of Event
    June 25, 1996
    Report Date
    July 1, 1996
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED WITH A PREOPERATIVE DIAGNOSIS OF SEPSIS, INFECTED CENTRAL LINE. THE CENTRAL VENOUS CATHETER WAS SURGICALLY REMOVED FROM THE PT AND IT WAS DISCOVERED THAT THERE WAS A HOLE IN THE CATHETER THAT CONTRIBUTED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS CATHETER Implant CENTRAL VENOUS CATHETER DQO NEOSTAR MEDICAL TECHNOLOGIES, INC. CV-332K AV197

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L