BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALY-NATE

    MDR report key: 2933130 · Received January 25, 2013

    Report

    Report Number
    2933130
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 25, 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

    WHEN NURSE REMOVED DIALYNATE SYSTEM FROM PACKAGING, SHE PULLED TO EXTEND BOTH LINES ON COIL TO BE SAME SIDE OF COIL. WHEN THIS WAS DONE, THE PIECE NEAR THE BURETROL TORE FROM THE COIL SYSTEM AND THE PRODUCT COULD NOT BE USED. THE COILED PART EVENTUALLY BROKE OFF. THIS FACILITY IS SEEING A TREND WITH THIS PRODUCT. PRODUCT WAS NOT ACTUALLY USED ON THE PATIENT. NO PATIENT HARM OCCURRED.THE LOCAL PRODUCT REP IS WORKING WITH A HOSPITAL REP TO REPLACE ALL OF THE CURRENT PRODUCTS WITH THIS LOT NUMBER. STAFF ARE CONTINUING TO USE THE PRODUCT LOT NUMBERS UNTIL REPLACEMENTS ARE FOUND. STAFF HAVE BEEN EDUCATED ON INSPECTING CAREFULLY PRIOR TO USING FOR ANY BREAKS OR HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36184 DIALY-NATE CATHETER, PERITONEAL DIALYSIS FKO UTAH MEDICAL PRODUCTS, INC. * 1121990

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO