BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE¿ CLEAR CONNECTOR

    MDR report key: 22206725 · Received June 13, 2025

    Report

    Report Number
    9617594-2025-01259
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 20, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619042509
    PMA / PMN Number
    K970855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A PHOTO WAS RETURNED SHOWING THE PACKAGING INFORMATION OF THE SYRINGES USED WITH THE MICROCLAVE. NO SYRINGE WAS RETURNED FOR INSPECTION. RECEIVED ONE (1) OPENED/UNUSED 011-MC100 MICROCLAVE AND SIXTY-FOUR (64) NEW 011-MC100 MICROCLAVES FOR INSPECTION. NO DEFECTS OR ANOMALIES NOTED. THE RETURNED USED SAMPLE WAS CONNECTED WITH A NEW 3ML BD SLIP-TIP SYRINGE (PROVIDED BY ICU MEDICAL), AND NO ANOMALIES, ISSUES, OR REBOUNDING SENSATIONS WERE NOTED. THEY WERE CONNECTED AS EXPECTED AND, UNDER NORMAL HANDLING, WOULD NOT DISCONNECT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. WITHOUT THE RETURN OF THE MATING DEVICE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) NEW. LIST # 011-MC100, MICROCLAVE¿ CLEAR CONNECTOR; LOT # 13963812, ONE (1) NEW. LIST # 011-MC100, MICROCLAVE¿ CLEAR CONNECTOR; LOT # 13706235, ONE (1) NEW. LIST # 011-MC100, MICROCLAVE¿ CLEAR CONNECTOR; LOT # 13679304, AND FIVE (5) NEW. LIST # UNKNOWN, 10ML SYRINGE; LOT # 241110. NO DEFECTS OR ANOMALIES NOTED. EACH OF THE RETURNED 10 ML SYRINGES WERE USED TO CONNECT TO EACH MICROCLAVE. ONE (1) OF THE MICROCLAVES HAD NO ISSUES CONNECTING TO EACH SYRINGE. TWO (2) OF THE MICROCLAVES COULD NOT ACHIEVE A FRICTION FIT WITH THE RETURNED SYRINGES. A SEPARATE ICU MEDICAL PROVIDED SLIP LUER SYRINGE WAS USED TO CONNECT TO EACH MICROCLAVE. THERE WERE NO ISSUES IN CONNECTING THAT SYRINGE TO THE MICROCLAVES. AN ICU MEDICAL PROVIDED MICROCLAVE WAS USED TO CONNECT TO THE SYRINGES WITH NO ISSUES. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE IS UNKNOWN. THE ISSUE COULD NOT BE ISOLATED TO THE SYRINGES OR TO THE MICROCLAVES; HOWEVER, WHEN USING A SEPARATE ICU MEDICAL PROVIDED SYRINGE, THERE WERE NO ISSUES IN CONNECTION. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REGARDING A MICROCLAVE¿ CLEAR CONNECTOR THAT THE BIOMEDICAL SYRINGES WERE BEING PUSHED OUT BY THE MICROCLAVE. DURING USE, THE MICROCLAVE NO LONGER PERFORMED THE PROPER LOCKING MECHANISM THAT IT ALWAYS USED TO, AND IT WAS NECESSARY TO MAINTAIN ALL THE PRESSURE IN THE PATIENT'S LINE THROUGH THE MICROCLAVE FOR DRUG ADMINISTRATION, WHICH COULD LEAD TO DISCONNECTIONS AND POTENTIAL SAFETY ISSUES. THE SYRINGES DISCONNECTED EVEN AFTER PERFORMING THE QUARTER TURN WHICH RESULTED IN DELAY IN THERAPY, HOWEVER THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344275 MICROCLAVE¿ CLEAR CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14144982 00840619042509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CLEANING SALINE SOLUTION