BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE CONNECTOR

    MDR report key: 2932288 · Received January 10, 2013

    Report

    Report Number
    2025816-2012-00076
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    May 30, 2012
    Report Date
    June 15, 2012
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR ANALYSIS AND INVESTIGATION: DEVICE RETURN: TWO (2) USED MC100 CLEAR MICROCLAVE CLEAR CONNECTORS WERE RETURNED TO THE MFG. FOR ANALYSIS AND INVESTIGATION. THE TWO (2) RETURNED MC100 MICROCLAVE CONNECTORS WERE NUMBERED SAMPLE #1 AND SAMPLE #2. ALTHOUGH REQUESTED NOT MATING DEVICES WERE RETURNED. VISUAL ANALYSIS DURING DECONTAMINATION RECORDED SAMPLE #1 RESIDUAL LEAKAGE BETWEEN SILICONE SEAL AND CLEAR CAP HOUSING; LEAKAGE BETWEEN SILICONE SEAL AND CLEAR CAP HOUSING; LEAKAGE ALSO NOTED EXTERNALLY AT JUNCTION OF BODY CAP AND SPIKE THREADS. VISUAL ANALYSIS DURING DECONTAMINATION WITH SAMPLE #2 RECORDED THE SILICONE SEAL WAS PARTIALLY OUT OF THE CAP BODY. THIS CONDITION WAS MOST LIKELY CAUSE DUES TO USE/ACCESS WITH INCOMPATIBLE MATING DEVICE WITH INSIDE DIAMETER > 0.110". THE REPORT ALSO NOTES RESIDUAL LEAKAGE NEAR THE CAPA THREADS; NO VISIBLE SILICONE SEAL / COMPONENT DAMAGES. DIMENSIONAL ANALYSIS RECORDED NO DIMENSIONAL NON CONFORMANCES. ADDITIONAL ENGINEERING ANALYSIS WERE PERFORMED. THE RETURNED MC100 CONNECTORS WERE DISASSEMBLED AND INSPECTED. THE RESULTS RECORDED SAMPLE #1 EXHIBITED AN 'L' SHAPED PUNCTURE THROUGH THE WALL OF THE SEAL. THIS CONDITION WOULD CAUSE LEAKAGE. SAMPLE # 2 RECORDED NO DAMAGES/ANOMALIES WITH THE INTERNAL COMPONENTS. FUNCTIONAL TESTING WAS PERFORMED. DUE TO THE NOTED INTERNAL COMPONENT DAMAGE ON SAMPLE #1 FUNCTIONAL TESTING WAS NOT PERFORMED. SAMPLE #2 WAS REASSEMBLED AND TESTED. THE RESULTS RECORDED SAMPLE #2 PASSED PERFORMANCE TESTING. CONCLUSION: THE TESTING AND ANALYSIS OF THE RETURNED SAMPLES DOCUMENTED VARIOUS COMPONENT DAMAGES/PUNCTURE MARKS CAUSED DURING USAGE WITH INCOMPATIBLE MATING DEVICES. FOLLOW UP INFORMATION RECEIVED FROM THE FACILITY CONTACT: FACILITIES INTERNAL INVESTIGATION OF THIS INCIDENT AND INVOLVED DEVICES ARE REPORTING THE EVENT/DEVICE ISSUES WERE ATTRIBUTABLE TO THE ARROW INFUSION CATHETER. NO SPECIFIC AND OR ADDITIONAL INFORMATION REGARDING THE NATURE OF THE CATHETER DEFECT WAS PROVIDED TO THE MC100 CONNECTOR MANUFACTURER.

    Description of Event or Problem · 1

    FDA/MEDSUN REPORT REC'D. CONCERNING A (B)(6) 2012 INCIDENT THAT INVOLVED USE OF MC100 MICROCLAVE CLEAR CONNECTOR AND ARROW (B)(4) SINGLE LUMEN INFUSION CATHETER . THE MEDSUN REPORTS STATES "...MICROCLAVE CONNECTOR BECAME DISCONNECTED FROM THE SINGLE LUMEN INFUSION CATHETER WHEN THE TUBING WAS BEING REMOVED AND FELL OFF. AIR CAME INTO THE LINE AND THE PATIENT BECAME SYMPTOMATIC FOR AN AIR EMBOLISM. PATIENT WENT INTO CARDIAC ARREST, SUSTAINED NEUROLOGICAL INJURY AND WAS PLACED IN NICU (NEUO ICU). PATIENT IS NOW IN REHAB." NO ADD'L. PATIENT INFORMATION RELEASED TO THE MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16216 CLAVE CONNECTOR NEEDLELESS CONNECTOR FPA ICU MEDICAL INC. MC100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI IV ADMINISTRATION DEVICES| ARROW (B)(4) SINGLE LUMEN INFUSION CATHETER| ARROW# (B)(4) KIT CATH MAC DUAL LUM