BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK DOUBLE LUMEN CENTRAL VENOUS CATHETER

    MDR report key: 149353 · Received February 17, 1998

    Report

    Report Number
    149353
    Event Type
    Injury
    Date Received
    February 17, 1998
    Date of Event
    February 3, 1998
    Report Date
    February 17, 1998
    Manufacturer
    COOK CRITICAL CARE/ DIVISION OF COOK INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COOK DOUBLE LUMEN CENTRAL VENOUS CATHETER BROKE OFF AFTER HAVING BEING INSERTED IN RIGHT SUBCLAVIAN OF PT. THE CATHETER HAD BEEN INSERTED ON 02-02-1998. AT 8:30 PM ON 02-02-1998, WHEN VIEWING CHEST X-RAY BECAME AWARE OF BREAK IN THE CATHETER. PT TRANSFERRED TO NICU AND TO ANOTHER FACILITY FOR REMOVAL OF CATHETER. *PRODUCT LABEL WAS DISCARDED BY MISTAKE AT THE TIME CAHTETER WAS USED ON PT. INITIALLY THE PHYSICIAN TRIED USING A FEMORAL CATHETER AND WHEN HE COULD NOT INSERT IT, HE DECIDED TO USE THE CENTRAL VENOUS CATHETER. THE LABEL PLACED IN THE MEDICAL RECORD WAS FOR THE FEMORAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK DOUBLE LUMEN CENTRAL VENOUS CATHETER DOUBLE LUMEN CENTRAL VENOUS CATHETER SET DQO COOK CRITICAL CARE/ DIVISION OF COOK INC. CUDLM-401J-RSC NA*

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention