BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TD CATHETER

    MDR report key: 4896000 · Received July 2, 2015

    Report

    Report Number
    2025816-2015-00077
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    April 25, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: A TWO YEAR REVIEW OF THE COMPLAINT DATABASE FOR THIS LIST NUMBER REPORTED PRODUCT ISSUE (PORT LEAKAGE) AND INVESTIGATION FINDINGS (RETURNED COMPLAINT UNITS) RECORDED. NO ADD'L CONFIRMED COMPLAINTS OF THIS NATURE. THE REVIEW ALSO VERIFIED NO ADVERSE TRENDS ASSOCIATED WITH THIS LIST NUMBER. FINDINGS: THE INVOLVED CATHETER DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS AND CONFIRMATION. INITIAL AND F/U INFO RECEIVED DID NOT REPORT ANY VISUAL DEFECTS/DAMAGES WITH THE DEVICE LUMENS, BALLOON, THERMISTOR OR PORT CONNECTORS. THE SOURCE, ORIGIN AND OR ROOT CAUSE OF THE REPORTED PRODUCT ISSUE "BLOOD SEEN IN THE CATHETER PORT" REMAINS UNK.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED REPORTING PROCEDURAL AND PRODUCT ISSUES WITH USE OF ONE 41232-02 8F 5 LUMEN, 110CM, RA/RV, HEPARIN COATED TD CATHETER, AND UNIDENTIFIED MONITOR EQUIPMENT, PRINTERS, CABLES UNK ANCILLARY EQUIPMENT AND DEVICES. THE REPORT DESCRIBES THE EVENT AS FOLLOWS: "WEDGED BALLOON CATH UNTIL WAVEFORM CHANGE. NOTICED IT WASN'T PRINTING. RELEASED THE BALLOON, WENT OVER TO PRESS PRINT, CAME BACK TO WEDGE BALLOON AGAIN BUT NOTICED BLOOD IN THE PORT. DOCTOR TO BEDSIDE. CXR DONE. NO DISTRESS NOTED BY PT BUT CONSTANT COUGH, EVEN DURING ATTEMPTED WEDGE". THE 41232-02 CATHETER WAS REMOVED, REPLACED AND DISCARDED. THE CATHETER WOULD HAVE BEEN PRE-TESTED DURING INITIAL SET-UPS AND PRE-INSERTION. F/U INFO REPORTED CXR SHOWED CORRECT CATHETER PLACEMENT, NO ISSUES SEEN WITH CATHETER DEVICE COMPONENTS. UPON REMOVAL THERE WERE ON REPORTED AND OR NOTED 41232-02 DEVICE DEFECTS, COMPONENT DAMAGES AND OR ABNORMALITIES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431345 8F TD CATHETER CATHETER DQE ICU MEDICAL, INC. 41232-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR