BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR CONNECTOR

    MDR report key: 9309212 · Received November 12, 2019

    Report

    Report Number
    9617594-2019-00386
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    October 24, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 011-MC100, MICROCLAVE CLEAR CONNECTOR WAS RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, THE SILICONE SEAL OF THE MICROCLAVE WAS STUCK DOWN. SEAL TEARING WAS PRESENT ON THE SEAL. NO MATING DEVICES WERE RETURNED WITH THE SAMPLE. THE MICROCLAVE WAS DISASSEMBLED AND SPIKE DAMAGE WAS IDENTIFIED. THE REPORTED COMPLAINT OF SEAL STICKDOWN WAS CONFIRMED. THE PROBABLE CAUSE IS ACCESS WITH AN INCOMPATIBLE MATING DEVICE. THE DFU STATES: DO NOT USE NEEDLES OR LUER CAPS ON CLAVES. THE MICROCLAVE CONNECTOR IS COMPATIBLE WITH LUERS WITH AN INTERNAL DIAMETER (ID) BETWEEN 0.062" (1.55 MM) AND 0.110" (2.8 MM). A DEVICE HISTORY REVIEW (DHR) FOR LOT# 3911204, 4052256, 3911484 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 EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED THREE POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 3911204 (EXPIRY DATE 12/01/2023 , MFR DATE 12/01/2018), 4052256 (EXPIRY DATE 04/01/2024, MFR DATE 04/01/2019), AND 3911484 (EXPIRY DATE 12/01/2023, MFR DATE 12/01/2018).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A MICROCLAVE CONNECTOR THAT WAS BEING USED ON A TRIPLE LUMEN CENTRAL LINE CATHETER ON A PATIENT IN THE INTENSIVE CARE UNIT (ICU). WHEN THE LINE WAS INSPECTED, IT WAS NOTED THAT TWO OF THE LUMENS WERE BLOCKED, AND THE THIRD LUMEN WAS PATENT. ONE OF THE BLOCKED LUMENS HAD TOTAL PARENTERAL NUTRITION (TPN) IN THE LINE. WHEN THE ADMINISTRATION SET WAS REMOVED, IT WAS FOUND THAT THE ONE-WAY VALVE ON THE CONNECTOR REMAINED RETRACTED AND AIR WAS NOTED IN THE LINE. THE CENTRAL LINE WAS IMMEDIATELY CLAMPED OFF, THE LINE WAS ASPIRATED, A NEW CONNECTOR WAS ATTACHED AND THE LINE WAS FLUSHED. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104587 MICROCLAVE® CLEAR CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR UNSPEC ADMINISTRATION SET, MFR UNK.| UNSPEC TRIPLE LUMEN CATHETER, MFR UNK.