BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONECTOR TEGO¿

    MDR report key: 8668607 · Received June 4, 2019

    Report

    Report Number
    9617594-2019-00158
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 13, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709096271
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. A DHR LOT#3942822 AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCE'S WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A LEAK OF SEROHEMATIC FLUID THROUGH A CRACK IN THE SILICONE STRUCTURE OF A TEGO CONNECTOR. THE PATIENT INVOLVED IS A (B)(6) MALE, INITIALS J.D.B., DIAGNOSED WITH CHRONIC RENAL INSUFFICIENCY. DIALYSIS THERAPY WAS STARTED THROUGH A TUNNELED CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN, COVERED WITH A TRANSPARENT WOUND DRESSING. IT WAS NOTED THAT THE GAUZE COVERING THE LUMENS WAS SATURATED WITH BLOOD. THE LEAK APPEARED TO BE THROUGH THE TEGO CONNECTOR ON THE VENOUS LUMEN. THE BLOOD LOSS WAS REPORTEDLY LESS THAT 150ML. THE CATHETER WAS CLAMPED AND THE CONNECTOR WAS CHANGED. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR TESTING. HEMODIALYSIS WAS RESUMED PER PROTOCOL AND ANTIBIOTICS WERE ADMINISTERED AS A PROPHYLACTIC MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461465 CONECTOR TEGO¿ SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3942822 00887709096271

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR