BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR

    MDR report key: 8515749 · Received April 15, 2019

    Report

    Report Number
    9617594-2019-00117
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 25, 2019
    Report Date
    March 25, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709038905
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) USED MC33450 7" (18 CM) APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR, ROTATING LUER LOT#3920631 AND ONE (1) USED REDCAP WITH LIST AND LOT# UNKNOWN WERE RECEIVED FOR EVALUATION ON APRIL 17, 2019. THE DEVICE WAS RETURNED WITH THE RED DEAD-END LUER CAP ON THE FEMALE LUER OF THE MIRCOCLAVE AND WHEN THE CAP WAS REMOVED THE SEAL WAS STUCK DOWN. THE RED DEAD-END LUER CAP IS AN INCOMPATIBLE MATING DEVICE. SUBSEQUENT DISASSEMBLY REVEALED A SEAL PUNCTURE AND SPIKE DAMAGE TYPICAL OF ACCESS WITH AN INCOMPATIBLE MATING DEVICE(S). THE PROBABLE CAUSE OF THE MICROCLAVE SEAL STICK DOWN AND SUBSEQUENT LEAKAGE IS ACCESS WITH A DEAD END LUER CAP DURING USE. THE MICROCLAVE DFU STATES: DO NOT USE NEEDLES, BLUNT CANNULAS OR LUER CAPS ON CONNECTORS. A DEVICE HISTORY REVIEW FOR LOT#3920631 AND RELEVANT COMMODITIES WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS YET TO BE RECEIVED. CONCOMITANT PRODUCTS: COVIDIEN MONOJECT TUBE HOLDER (ITEM NUMBER 8881225216), CAREFUSION MAXGUARD EXTENSION SET WITH TWO NEEDLELESS Y-SITES (ITEM NUMBER MX9178), COVIDIEN VACUTAINER (UNKNOWN ITEM NUMBER).

    Description of Event or Problem · 1

    THE EVENT INVOLVES A CUSTOMER REPORT OF PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR THAT HAD BLOOD FLOWING OUT OF IT. IT WAS REPORTED AN INTRAVENOUS (IV) LINE WAS STARTED ON A PATIENT, BLOOD WAS DRAWN FROM THE IV HUB USING A COVIDIEN VACUTAINER, THEN THE EXTENSION SET WAS CONNECTED TO THE IV HUB AND FLUIDS STARTED. THE PATIENT WAS LATER DISCONNECTED TO USE THE BATHROOM, AND THE DEVICE WAS COVERED WITH A GREEN CAP. IT WAS REPORTED THAT BLOOD STARTED FLOWING OUT OF THE EXTENSION SET NONSTOP. THE DEVICE WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308921 7" (18 CM) APPX 0.39 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3920631 00887709038905

    Patients

    Seq Age Sex Outcome Treatment
    1