BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONECTOR TEGO¿

    MDR report key: 21633942 · Received March 18, 2025

    Report

    Report Number
    9617594-2025-00496
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 29, 2025
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A2 - DATE OF BIRTH - THE PATIENTS AGE WAS USED TO APPROXIMATE THE DATE OF BIRTH AS (B)(6) 1979. D4, G4: MODEL NUMBER IS NOT SOLD IN THE US BUT SIMILAR DEVICE IS SOLD UNDER MODEL D1000. THIS PRODUCT WAS USED FOR THE PRODUCT CODE AND 501K. THE INVESTIGATION IS PENDING COMPLETION. UPON COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A PHOTO WAS PROVIDED BY THE CUSTOMER SHOWING THE LAT -D1000 TEGO FOR INSPECTION. THE SEAL MEMBRANE WAS TORN. THE REPORTED COMPLAINT OF A TORN SEAL ON THE TEGO AND SUBSEQUENT NO FLOW CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE TORN SEAL IS DUE TO VARIATION ON TEGO SEAL MATERIAL WHICH HAS A DIRECT IMPACT ON FUNCTIONAL PERFORMANCE OF THE TEGO CONNECTOR WITH AN ADDITIONAL CONTRIBUTING FACTOR REGARDING UNEVEN ADHESIVE APPLICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED A REGARDING A TEGO¿ CONNECTOR THAT EXPERIENCED BREAKAGE AND LEAKAGE. IT WAS REPORTED THAT IN THE (B)(6) RENAL UNIT - DAVITA COLOMBIA S.A.S, A MECHANICAL FAILURE OCCURRED WITH A TEGO THAT WAS ADAPTED ON (B)(6)2025, AND ON ITS THIRD DAY OF USE IT EXERCISED FALLING BLOOD PRESSURE AND HIGH VENOUS PRESSURE OF THE CATHETER AND PREVENTED THE EXIT AND RETURN OF BLOOD THROUGH THE CONNECTOR WHILE CONNECTED TO MACHINE¿S LINES. RUPTURE OF THE MEMBRANE THAT COVERS THE AILERONS OF THE TEGO¿S THREAD. AFTER THE TEGO CONNECTOR WAS REMOVED AND THE LINES WERE DIRECTLY CONNECTED TO THE CATHETER IT SHOWED FUNCTIONED PROPERLY. THE EVENT WAS MENTIONED AS A NON-SERIOUS ADVERSE EVENT. A PICTURE WAS PROVIDED SHOWING THE PRODUCT. ACCORDING TO THE REPORT, THE EVENT OCCURRED DURING USE OF THE TEGO WITH A 46-YEAR-OLD MALE PATIENT WITH INITIALS (B)(6), WEIGHT 55.5 KILOGRAMS, HEIGHT 1.70 METERS, HEMODIALYSIS TREATMENT, DOSAGE OF HEPARINA 7500 UI, INITIAL BLOOD PRESSURE 163/107 MMHG, INITIAL CARDIAC RHYTHM 88/MIN, BLOOD PRESSURE AT THE END OF TREATMENT 165/105 MMHG, CARDIAC RHYTHM AT THE END OF TREATMENT 73/MIN. PATIENT DID NOT NEED TREATMENT SUSPENSION, MEDICINE ADMINISTRATION, VOLUME SUBSTITUTION, INTENSIVE CARE OR HOSPITALIZATION, AND WAS CONSIDERED RECOVERED. THERE WAS NO HARM SUCH AS DEATH, LIFE-THREATENING ILLNESS OR INJURY, PERMANENT DISABILITY, MEDICAL INTERVENTION (MEDICATIONS, HOSPITALIZATION) NOR DAMAGE. IT IS UNKNOWN IF THERE WAS DELAY IN THERAPY. (B)(6)2025. UPDATE: GCM RECEIVED AN EMAIL, ON (B)(6)2025, FROM MS. (B)(6), DIAGNOSTIC AND THERAPEUTIC SUPPORT ANALYST FROM DAVITA COLOMBIA, CONFIRMING THAT THERE WAS NO DELAY IN THERAPY. (B)(6)2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372442 CONECTOR TEGO¿ SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14145002 00887709096271

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male