BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD HEPARIN COATED CATHETER

    MDR report key: 6035440 · Received October 17, 2016

    Report

    Report Number
    2025816-2016-00162
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 8, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    874465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING INFLATION FAILURE WITH USE OF ONE (1) 41233-01 8F TD HEPARIN COATED 5 LUMEN CATHETER . THE 07/20 EVENT WAS REPORTED AS FOLLOWS "..SWAN BALLOON DEFLATED WHILE INSIDE PATIENT. SWAN REMOVED .. APPEARED INTACT. NEW SWAN USED. PATIENT WAS NOT HARMED." FOLLOW UP INFORMATION REPORTS USE OF A 8FR TERUMO SHEATH FOR INSERTION WAS USED. THE 41233-01 8F CATHETER DFU DOES STATE THE REQUIREMENT TO USE 8.5F OR LARGER SHEATH/INTRODUCER FOR THE 41233-01 8F TD CATHETER. ADDITIONAL INSTRUCTIONS FOR PRE-INSERTION TESTING ALSO INSTRUCT THE USER TO RETEST THE BALLOON FOR PROPER FUNCTION AFTER INSERTION THROUGH THE SHIELD/SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686404 TD HEPARIN COATED CATHETER TD HEPARIN COATED CATHETER DYG ICU MEDICAL, INC. 41233-01 66-453-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO 8F SHEATH