BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE CONNECTOR

    MDR report key: 4736570 · Received April 28, 2015

    Report

    Report Number
    2025816-2015-00022
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 20, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: THREE (3) USED 011-C3300 MICROCLAVE CONNECTORS AND ONE (1) PACKAGED 011-C3300, LOT 2930437; USED ARIES ADMIN EXT SET; ARIES STOPCOCK; BD VENFLON PRO CATHETER AND BD 10ML SYRINGE. VISUAL INSPECTION RECORDED TWO OF THE USED MICROCLAVE CONNECTORS SILICONE PLUGS WERE PROTRUDED; NO OTHER VISUAL ABNORMALITIES NOTED WITH THE REMAINING SAMPLES THAT WERE RETURNED. FUNCTIONAL TESTING: THE USED 011-C3300 AND PKGD SAME LOT SAMPLE WERE EACH PRESSURE LEAK TESTED PER THE APPLICABLE PROD SPEC. THE RESULTS RECORDED NO FUNCTIONAL ISSUES, THE SILICONE PLUGS RESET CORRECTLY, THERE WERE NO LEAKAGES AND OR OUT OF SPEC CONDITIONS. THE RETURNED MATING AND ACCESS DEVICES WERE CONNECTED TO REPLICATE THE USAGE SET-UPS AND TESTED. THE REPORT NOTED THE ONLY FEMALE LUER PORT AVAILABLE TO CONNECT A 011-C3300 MICROCLAVE WAS THE SIDEPORT OF THE STOPCOCK HANDLE, WHICH WAS TURNED OFF TO THE SIDEPORT. THE RESULTS SHOWED NO FLOW OR PERFORMANCE ISSUES, THE 011-C3300 CONNECTOR DEVICE/COMPONENTS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    INTL ((B)(6)) COMPLAINT REC'D REPORTING COMPONENT/PLUG PROTRUSIONS WITH USE OF TWO 011-C3300 MICROCLAVE CONNECTORS. LIMITED INFORMATION REC'D, DISTRIBUTOR REPORTS "SOMETIMES WHEN THEY DO THE WASHING CAP FORGET TO CLOSE TO THE CONNECTOR". THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. ADD'L RELEVANT EVENT INFO ALTHOUGH REQUESTED HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279681 MICROCLAVE CONNECTOR MICROCLAVE CONNECTOR FPA ICU MEDICAL, INC. 011-C3300 2930437

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARIES STOPCOCK| BD VENFLON PRO CATHETER| ARIES ADMIN EXT SET| BD 10ML SYRINGE