BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAY

    MDR report key: 370685 · Received January 10, 2002

    Report

    Report Number
    1820334-2002-00006
    Event Type
    Injury
    Date Received
    January 10, 2002
    Date of Event
    December 2, 2001
    Report Date
    December 14, 2001
    Manufacturer
    COOK INCORPORATED
    Product Code
    KRK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TRANSFERRED FROM ANOTHER HOSPITAL WITH FEVER OF 106 DEGREES AND CYANOSIS. ADMITTED TO HOSPITAL IN 2001 TO PICU, IN CRITICAL CONDITION, WITH OVERWHELMING SEPSIS. PHYSICIAN ATTEMPTED CENTRAL LINE PLACEMENT IN RIGHT FEMORAL VEIN TO GET IV ACCESS. DURING PROCEDURE, THE GUIDEWIRE KINKED ON DISTAL END, MAKING PASSAGE OF CATH IMPOSSIBLE. GUIDEWIRE WAS CUT TO ACCOMODATE CATH AND THEN CATH WAS PLACED, GUIDED TO INSERTION SITE, GUIDEWIRE PULLED BACK, CATH INSERTED, UNABLE TO PULL OUT GUIDEWIRE. CATH REMOVED, GUIDEWIRE WAS STUCK IN SUBCUTANEOUS TISSUE. REMOVED BY MAKING A SMALL SKIN INCISION TO REMOVE THE GUIDEWIRE. ON EXAM THE WIRE WAS KINKED/APPEARS KNOTTED AT THE END. PT EXPIRED FROM SEPSIS AND DISSEMINATED INTRAVASCULAR COAGULOPATHY TWO DAYS POST. NUMEROUS BLOOD PRODUCTS WERE TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAY CENTRAL VENOUS CATHETER KRK COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other