BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK DIALYSIS CATHETER

    MDR report key: 3071219 · Received April 11, 2013

    Report

    Report Number
    3071219
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE PRODUCT. COOK DIALYSIS CATHETER. CUFF CAME LOOSE. DEVICE REMOVED W/O HARM. BARD HEMOSPLIT 16FR X 19CM, LOT REWB1784.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155570 COOK DIALYSIS CATHETER BARD HEMOSPLIT 16FR X 19CM MSD BARD MEDICAL DIVISION REWB1784

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention