BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDO SINGLE LUMEN TPN CATHETER SET

    MDR report key: 3231699 · Received July 10, 2013

    Report

    Report Number
    1820334-2013-00276
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS PER COMPLAINT FORM: "THE FIRST CATHETER WAS PUT ON A (B)(6) CHILD ON (B)(6) 2013. THERE WAS A LEAK AT THE LEVEL OF THE CHANGE OF CALIBER. THE CATHETER COULD NOT BE PLACED. SECOND PROCEDURE WAS ON (B)(6) 2013. THE CATHETER WAS PLACED. ADDITIONAL INFO REQUESTED (B)(6) 2013. ON (B)(6) 2013 THE CATHETER HAD TO BE REMOVED BECAUSE THEY NOTICED THE SAME ISSUE. BECAUSE OF THIS, THEY HAD TO PLACE A VITAL PORT ON THE CHILD. THE FIRST PRODUCT USED ON (B)(6) WAS BINNED. THE SECOND ONE USED ON (B)(6) WILL BE AVAILABLE FOR COLLECTION. CATHETER FOR PARENTERAL FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319015 REDO SINGLE LUMEN TPN CATHETER SET DQO COOK, INC. NA 3687244

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention