BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE CONNECTOR

    MDR report key: 4230298 · Received October 21, 2014

    Report

    Report Number
    2025816-2014-00117
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 29, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE(S) RETURNED: ONE (1) USED 081-C3300, MICROCLAVE CONNECTOR; ONE SC-4N STOPCOCK; ONE PACKAGED STOPCOCK MANIFOLD. VISUAL ANALYSIS RECORDED THE "AS-RECEIVED" 081-C3300 MICROCLAVE PLUG WAS PROTRUDING FROM THE BODY, INTERNAL COMPONENTS SHOWED EVIDENCE OF BLOOD/CLOTTING. THERE WERE NO OTHER VISUAL ABNORMALITIES WITH THE RETURNED MATING/ACCESS DEVICES. ENGINEERING EVALUATIONS: DIMENSIONAL EVALUATION OF THE RETURNED DEVICE MATING COMPONENTS RECORDED: SC-4N STOPCOCK ISO MALE LUER TAPER: PASS; MALE LUER INSIDE DIAMETER SPEC. 0.062" - 0.110" MEASURED 0.116" FAIL. THE 3-PORT STOPCOCK MANIFOLD MET/PASS BOTH ISO TAPER AND ID SPECIFICATIONS. ALTHOUGH NOT ALWAYS REPEATABLE PREVIOUS ENGINEERING ANALYSIS OF SILICONE PLUG PROTRUSIONS HAVE BEEN REPLICATED UNDER CERTAIN USAGE CONDITIONS WHERE THE MICROCLAVE ASSEMBLY IS EXPOSED TO HIGH BACK PRESSURES. HIGH PRESSURES CAN BE GENERATED WITH SMALL SYRINGES (10CC AND SMALLER). WHEN HIGH PRESSURES ARE GENERATED WITH INFUSION OR FLUSHING THROUGH SMALL SYRINGES IT IS IMPORTANT TO ISOLATE THE MICROCLAVE BY TURNING THE STOPCOCK HANDLE SO THAT IT IS OFF TO THE PORT THAT THE MICROCLAVE IS ATTACHED TO. DETAILED ANALYSIS OF THE INVOLVED COMPONENT(S) DESIGN ATTRIBUTES, MATERIALS, MANUFACTURING AND ASSEMBLY PROCESSES AND EQUIPMENT HAVE BEEN PERFORMED. THE CONTINUOUS IMPROVEMENT TEAMS HAVE IDENTIFIED AND ARE PURSUING SEVERAL DESIGN AND PROCESSING IMPROVEMENTS THAT ARE EXPECTED TO ADDRESS PLUG PROTRUSIONS FROM OCCURRING WHEN HIGH PRESSURES ARE GENERATED WITHIN THE FLUID CIRCUIT. FINDINGS: BASED ON THE VISUAL EVALUATION OF THE AS RECEIVED 081-C3300 MICROCLAVE CONNECTOR THE REPORTED COMPONENT ISSUE WAS CONFIRMED. ALTHOUGH THE EXACT CAUSE(S) OF THE COMPONENT CONDITION ARE UNKNOWN, USAGE/TECHNIQUE APPEARS TO HAVE CONTRIBUTED TO THIS EVENT/ISSUE. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN ENTERED IN OUR COMPLAINT DATABASE FOR CONTINUAL MONITORING AND TRENDING.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED REPORTING COMPONENT ISSUES WITH USE OF ONE 081-C3300 MICROCLAVE CONNECTOR. IT WAS REPORTED ".. SILICONE PLUG WAS POPPED OUT OF MICROCLAVE CONNECTOR. THE MICROCLAVE WAS CONNECTED TO KAWASUMI THREE-WAY STOPCOCK." THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCES AND OR OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668254 MICROCLAVE CONNECTOR CONNECTOR FPA ICU MEDICAL, INC. 081-C3300 2811205

    Patients

    Seq Age Sex Outcome Treatment
    1 SC-4N STOPCOCK| UNKNOWN SYRINGES NOI| SC MANIFOLD