BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 8911667 · Received August 20, 2019

    Report

    Report Number
    9617594-2019-00280
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 2, 2019
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIFTEEN NEW D1000 TEGO CONNECTORS WERE PRESSURE AND VACUUM LEAK TESTED. EACH MET PRESSURE AND VACUUM LEAK EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THE PRODUCT COMPLAINT OF LEAKAGE WAS UNABLE TO BE CONFIRMED WITH THE NEW D1000 TEGO CONNECTORS RETURNED FOR INVESTIGATION. A DHR (DEVICE HISTORY REVIEW) FOR LOT# 4032903 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS UNKNOWN. THE EVENT INVOLVED A TEGO CONNECTOR THAT EXPERIENCED A CRACK AND BLOOD WAS NOTED TO BE LEAKING FROM THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704864 TEGO® CONNECTOR NEUTRAL-PRESSURE NEEDLELESS VALVE-CONNECTOR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4032903 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1