BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO¿ CONNECTOR

    MDR report key: 20688469 · Received November 14, 2024

    Report

    Report Number
    9617594-2024-01613
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 26, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026059
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY RECEIVED ONE (1) USED. LIST #D1000, TEGO¿ CONNECTOR, APPX 0.05 ML; LOT #13938364 AS RECEIVED, NOTICED SOME TEARING NEAR ONE OF THE POST SEAL, ALSO A SMALL HOLE ON THE TOP SILICONE SEAL. RETURNED SAMPLE FAILS LEAK TEST. CONFIRMED CUSTOMER COMPLAINT OF HOLE OR DEFECT IN OUTER COATING OF TEGO CAP. PROBABLE CAUSE, UNKNOWN. A DEVICE HISTORY REVIEW FOR THE LOT # AND RELEVANT COMMODITIES WERE REVIEWED, THE FOLLOWING DISCREPANCY WAS IDENTIFIED: LOT #: 13899645, 13899644 DISCREPANCY: TEGO SEAL WITH OCCLUDED WINDOW COVERING THE RIB FROM THE TEGO BODY. ACCORDING TO THE SPECIFICATION THE RIB FROM THE TEGO BODY SHOULD PASS THROUGH THE WINDOW. QUANTITY IMPACTED AND SAMPLING RESULTS (FAIL/PASS): 100% INSPECTION, 198,325 UNITS WERE FOUND AFFECTED WITH OCCLUDED WINDOW" "DURING VISUAL INSPECTION ON. AFTER PERFORMING FUNCTIONAL TEST TM 0000090 THE WINDOW AREA STILL OCCLUDED AND THE RIB IS UNDER SILICONE PART. TOTES1-4 WERE AFFECTED.".

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TEGO¿ CONNECTOR REPORTER STATED THAT A HOLE OR DEFECT IN OUTER COATING OF TEGO CAP CAUSED BLOOD TO LEAK OUT AND AIR TO LEAK INTO THE PATIENT¿S CATHETER. THE EVENT HAPPENED DURING PATIENT USE AND AIR DRAWN INTO CONNECTOR. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297583 TEGO¿ CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13938364 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CATHETER, MFR UNK.