BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONECTOR TEGO

    MDR report key: 10152988 · Received June 15, 2020

    Report

    Report Number
    9617594-2020-00176
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    February 11, 2020
    Report Date
    May 21, 2020
    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

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER A PHOTOGRAPH WAS PROVIDED AND EVALUATED. THE PHOTO SHOWS TWO TEGOS. LEAKAGE IS EVIDENT FROM UNDER THE SEAL OF ONE TEGO. THE EXACT SOURCE OF THE LEAK IS NOT CLEAR FROM THE IMAGE PROVIDED. NO OTHER DAMAGE OR ANOMALIES CAN BE SEEN. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4080906 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE PHOTO PROVIDED, THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED. WITHOUT A RETURNED SAMPLE A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT WAS ADMITTED TO THE HEMODIALYSIS ROOM, WANDERING ON HER OWN, SUBSEQUENT DISCHARGED FROM THERAPY IN ADEQUATE CONDITIONS, WITHOUT COMPLICATIONS OR EVENTS. THE PATIENT WAS BLEEDING FROM THE VASCULAR ACCESS THAT IMPREGNATED THE ORIFICE GAUZE AND THE ONE THAT COVERED THE CATHETER LUMENS. UNDER ASEPTIC TECHNIQUE, THE ACCESS WAS CHECKED, IT WAS NOTED A HEALTHY ORIFICE, WITHOUT LEAKAGE OF LUMENS; HOWEVER, THE TEGO RUBBER HAD A SLIGHT BLOOD DRIP THAT INCREASED WITH MOBILIZATION. THE CLAMPS WERE CLOSED, ALTHORUGH THE CATHETER MATERIAL WAS ALREADY EVIDENCED WORN OUT. THE LUMENS WERE LEFT WITH THE LUER LOCK, COVERED WITH STERILE MATERIAL, GAUZE, AND FIXOMULL. THE PATIENT STAYED UNDER CLINICAL OBSERVATION, BUT NO FURTHER BLEEDING WAS EVIDENT. THERE EVENT OCCURRED DURING PATIENT USE, BUT NO ADVERSE EVENT WAS REPORTED AND NO ONE WAS HARMED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616468 CONECTOR TEGO SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4080906 00887709096271

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR