BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRAL VENOUS CATHETER

    MDR report key: 5067 · Received June 11, 1993

    Report

    Report Number
    5067
    Event Type
    Death
    Date Received
    June 11, 1993
    Date of Event
    January 20, 1993
    Report Date
    April 23, 1993
    Manufacturer
    UNKNOWN
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED FOR REPLAC EMENT OF A CENTRAKL VENOUS CATHETER. THE CATHETER TO BE REMOVED HAD BEEN IMPLANTED BY ANOTHER FACILITY. THE ATTEMPT TO REMOVE THE CATHETER RESULTED IN ONLY PARTIAL REMOVAL AND A "CARDIAC TAMPONADE DUE TO AN INDWELLING CATHETER WITH THE TIP CHRONICALLY PENETRATING AND PERFORATING THE RIGHT ATRIUM" WHICH WAS DEFINED ON AUTOPSY. RETREIVAL DEVICES USED TOATTEMPT COMPLETE REMOVALINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRAL VENOUS CATHETER DXG UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Death