BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING DRAINAGE CATHETER NEEDLE SET

    MDR report key: 3231839 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00267
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. WITHOUT THE COMPLAINT DEVICE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. BASED ON THE EVENT DESCRIPTION THE MOST LIKELY SCENARIO IS THAT THE CATHETER BECAME CAUGHT ON PATIENT ANATOMY. THE CATHETER SUBSEQUENTLY SEPARATED WHEN THE WITHDRAWAL FORCE EXCEEDED THE DESIGN. QUALITY CONTROL VERIFIES THE SURFACE OF THE CATHETER IS CLEAN AND FREE OF DAMAGE. THE STRENGTH AND ELONGATION OF A SAMPLE EACH LOT OF TUBING ARE VERIFIED AS WELL. WE ARE UNABLE TO DETERMINE EXACTLY WHAT LED TO THIS FAILURE MODE. THERE IS INSUFFICIENT INFORMATION TO ESTABLISH A ROOT CAUSE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS INSUFFICIENT RISK TO WARRANT RISK REDUCTION ACTIVITIES.

    Description of Event or Problem · 1

    UPON INTRODUCING CATHETER INTO KIDNEY FOR A NEPHROSTOMY, THE WHITE HUB FELL OFF. A WIRE WAS INSERTED INTO THE CATHETER TO EXCHANGE FOR A NEW CATHETER. THE CATHETER BEGAN TO BREAK APART INTO SMALL PIECES UPON REMOVAL (1820334-2013-00267). FRAGMENTED PIECES OF CATHETER WERE RETRIEVED FROM THE KIDNEY. ANOTHER COOK DRAINAGE CATHETER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324728 RING DRAINAGE CATHETER NEEDLE SET DWO COOK, INC. NA 2828162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention