BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALY-NATE

    MDR report key: 2921576 · Received January 14, 2013

    Report

    Report Number
    2921576
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 14, 2013
    Manufacturer
    UTAH MEDICAL PRODUCTS INC.
    Product Code
    FKO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DIALYNATE SYSTEM FROM PACKAGING PULLED TO EXTEND BOTH LINES ON COIL TO BE ON SAME SIDE OF COIL. THE PIECE CONNECTING TO THE BURETROL WAS TORN FROM THE COIL SYSTEM AND PRODUCT COULD NOT BE USED. NO HARM TO PATIENT. DEFECTIVE PRODUCT EXCHANGED WITH THE MANUFACTURER FOR NEW PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19838 DIALY-NATE CATHETER, PERITONEAL DIALYSIS FKO UTAH MEDICAL PRODUCTS INC. 4000527 1121990

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR DIALYSIS