BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CENTRAL VENOUS CATHETER TRAY

    MDR report key: 7021 · Received July 17, 1992

    Report

    Report Number
    7021
    Event Type
    Death
    Date Received
    July 17, 1992
    Date of Event
    June 14, 1992
    Report Date
    June 19, 1992
    Manufacturer
    COOK INCORPORATED
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SIXTEEN MONTH OLD MALE, IN RADIOLOGY, SUFFERED CARDIAC ARREST, RESUSCITATION UNSUCCESSFUL. EXPIRED. LEFT CVC CATHETER IN PLACE AT TIME OF ARREST. X-RAY 24 HOURS PREVIOUSLY, SHOWED CATHETER IN SUBCLAVIAN VEIN. PRELIMINARY POST-MORTUM INDICATES TPN FLUID IN PLEURAL SPACE.DEVICE LABELED FOR SINGLE USE. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CENTRAL VENOUS CATHETER TRAY N/A DXG COOK INCORPORATED 4.0 FR. 348962

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death