BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK TPN SINGLE LUMEN TPN CATHETER SET

    MDR report key: 3232292 · Received July 10, 2013

    Report

    Report Number
    1820334-2013-00279
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES TO THE PATIENT WERE NOTED. DEVICE BREAKAGE IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    RIGHT SUBCLAVIAN CENTRAL LINE SNAPPED INTO TWO PIECES. BABY STABLE. THE LINE WAS REMOVED DURING A STERILE BEDSIDE PROCEDURE. ANOTHER LINE WAS PLACED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315389 COOK TPN SINGLE LUMEN TPN CATHETER SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA F2630052

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention