BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONECTOR TEGO¿

    MDR report key: 8668637 · Received June 4, 2019

    Report

    Report Number
    9617594-2019-00159
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 11, 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 · 0

    THE SINGLE USED LAT-D1000 TEGO CONNECTOR WAS RETURNED WITH NO VISIBLE EXTERNAL DAMAGE. FUNCTIONAL TESTING REVEALED AN INTERNAL LEAK AND WHEN THE USED LAT-D1000 TEGO CONNECTOR WAS DISASSEMBLED THE SEAL HAD BEEN PUNCTURED AND TORN TYPICAL OF ACCESS WITH A SHARP INSTRUMENT SUCH AS A NEEDLE. THE COMPLAINT IS CONFIRMED, HOWEVER, THERE WERE NO MANUFACTURING ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER FOR TESTING AND INVESTIGATION, HOWEVER, THE INVESTIGATION IS NOT COMPLETE YET. 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 BLOOD THROUGH THE EDGES OF A TEGO CONNECTOR DURING DIALYSIS. THE PATIENT INVOLVED IS AN (B)(6) MALE, INITIALS R.A.C.M, DIAGNOSED WITH CHRONIC RENAL INSUFFICIENCY. THE BLOOD LOSS WAS LESS THAN 150ML AND WAS OBSERVED ON THE CONNECTOR OF THE ARTERIAL ACCESS. THE DEVICE WAS REPLACED AND THERE WAS NO ONE HARMED AS A RESULT OF THE EVENT. THE DEVICE WAS DISCARDED AND THERE IS NO SAMPLE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459898 CONECTOR TEGO¿ NEUTRAL-PRESSURE NEEDLELESS VALVE-CONNECTOR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3942822 00887709096271

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR