BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER-MULTI/MED SINGLE LUMEN

    MDR report key: 154067 · Received March 2, 1998

    Report

    Report Number
    154067
    Event Type
    Injury
    Date Received
    March 2, 1998
    Date of Event
    January 18, 1998
    Report Date
    January 26, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP./EDWARDS CRITICAL CARE DIV
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO DESK C/O IV LEAKING. UPON INSPECTION OF CLC 2X2 DRSG. FOUND TO BE SATURATED, ATTEMPT STERILE DRSG. CHANGE AND NOTED CL TO BE SUTURE TO NECK AND HUB OF CL EXPOSED. NO IV CATH NOTED. NO EDEMA OR REDNESS TO NECK AT INSERTION SITE. PT INSTRUCTED TO REMAIN STILL. CALL PLACED TO NURSING SUPERVISOR AND SURGICAL RESIDENT TO OBSERVE & EVALUATE CENTRAL LINE. XRAY ORDERED & CONFIRMED LINE TIP IN NECK. INVASIVE CARDIOLOGIST REMOVED CANNULA UNDER FLUOROSCOPY IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER-MULTI/MED SINGLE LUMEN Implant CENTRAL VENOUS CATHETER KIT DQO BAXTER HEALTHCARE CORP./EDWARDS CRITICAL CARE DIV M 11620K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention