BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CENTRAL VENOUS CATHETER TRAY

    MDR report key: 4492 · Received July 2, 1992

    Report

    Report Number
    4492
    Event Type
    Death
    Date Received
    July 2, 1992
    Manufacturer
    COOK INCORPORATED
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    16 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.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    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