BEUDAMED
    FDA Adverse Event Summary report: N

    8F TD CATHETER

    MDR report key: 5032760 · Received August 24, 2015

    Report

    Report Number
    2025816-2015-00090
    Date Received
    August 24, 2015
    Date of Event
    May 18, 2015
    Report Date
    July 1, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING INVESTIGATION AND ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE "AS RECEIVED" USED 41232-02 TD 8F TD CATHETER CONFIRMED THE BALLOON WAS RUPTURED/TORN. THE REPORT ALSO NOTED THE INFLATION LINE WAS TIED IN A KNOT. ENGINEERING ASSESSMENT OF THE 41232-02 CATHETER COMPONENTS DOCUMENTED NO PORTION OF THE BALLOON WAS MISSING. THE BALLOON DAMAGE WAS OBSERVED TO START IN THE MIDDLE OF THE BALLOON. THE REPORT NOTED THAT THE CHARACTERISTICS OF THIS TYPE OF BALLOON DAMAGE IS INDICATIVE OF MATERIAL STRESS FROM OVER INFLATION OF THE BALLOON. THE CATHETER DFU PROVIDES DETAILED INSTRUCTIONS (1.5CC) FOR INFLATING, TESTING AND USE OF THIS DEVICE COMPONENT/FUNCTION. FINDINGS: VISUAL INSPECTION OF THE AS-RECEIVED 41232-02 TD CATHETER CONFIRMED THE REPORTED PRODUCT ISSUE. ALTHOUGH THE EXACT CAUSE(S) ARE UNK, THE BALLOON COMPONENT DAMAGE IS CONSISTENT WITH INCORRECT USAGE (OVER-INFLATION)/TECHNIQUES.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED REPORTING INFLATION ISSUE WITH USE OF ONE 41232-02 TD 8F TD CATHETER, 5 LUMEN, 110CM, RA/RV, HEPARIN COATED, LF. THE REPORT DESCRIBES THE EVENT AS FOLLOWS: ...CATHETER IN PLACE NOT WEDGING. RN ATTEMPTED TO WEDGE CATHETER, NO RESISTANCE IN BALLOON. BALLOON RUPTURED; REPORTED TO PHYSICIANS...INSTRUCTED TO TIE INJECTION PORT IN A KNOT AND LABEL RUPTURED BALLOON...". THE DEVICE WAS REMOVED AND REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. DEVICE RETURN: ONE (1) USED 41232-02 TD 8F TD CATHETER.

    Description of Event or Problem · 1

    THIS IS THE MANUFACTURERS FOLLOW UP REPORT TO PROVIDE THE RETURN DEVICE INVESTIGATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559383 8F TD CATHETER CATHETER DYG ICU MEDICAL, INC. 41232-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR