BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROCLAVE® NEUTRAL CONNECTOR

    MDR report key: 23000053 · Received September 9, 2025

    Report

    Report Number
    9617594-2025-01819
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 10, 2025
    Report Date
    March 17, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619045593
    PMA / PMN Number
    K100434
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B2. CORRECTION: H1. CORRECTION H2.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST# B3300, CLAVE¿ NEUTRAL CONNECTOR: LOT# UNKNOWN. THE SILICONE PLUG WAS OBSERVED TO BE MISSING. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE RETURNED SAMPLE WAS OBSERVED TO BE MISSING ITS SILICONE PLUG, WHICH WOULD LEAD TO A LEAK. THE PROBABLE CAUSE OF THE MISSING SEAL IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTER: (B)(6). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO LOT NUMBER AVAILABLE FOR DEVICE HISTORY LOT REVIEW. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY INFORMATION IS MADE AVAILABLE.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT "THERE WAS CRACKED NAD (NEEDLESS ACCESS DEVICE). THEREFORE, THE PATIENT WAS NOT RECEIVING PGE (PROSTAGLANDIN E), AND THIS CAUSED THE PATIENT TO DESATURATE. THEY ALSO STATED THAT THE PATIENT HAS TETRALOGY OF FALLOT AND NEEDS PGE TO KEEP THE DUCT OPEN. THE PATIENT NEEDS MEDICATION TO INFUSE AT ALL TIMES TO PREVENT THE DUCT FROM CLOSING. THE PATIENT DID NOT RECEIVED MEDICATION FOR 30-45 MINUTES RESULTING THE PATIENT TO EXPERIENCE DESATURATING. THE PATIENT NEEDED INCREASE IN FIO2 AND FLOW. PATIENT'S VITAL SIGNS WERE STABLE PRIOR TO THE CRACKED NAD. STILL, THE PATIENT WAS DESATURATING, UNTIL THE NEW NAD WAS PUT IN THE LINE AND THEN PATIENT WAS FINE AFTER PUTTING THE NEW NAD. IT WAS ALSO STATED THAT THEY WENT ON PATIENT'S HIGH FLOW NASAL CANNULA FLOW AND OXYGEN. THEY INCREASED THE PGE DRIP RATE UNTIL THE PATIENT'S VITAL SIGNS WERE STABLE. INTERVENTION WAS REQUIRED. THUS, THERE WAS INJURY AND THERE WAS NO DEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418674 MICROCLAVE® NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00840619045593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening NASAL CANNULA, MFR UNKNOWN| PROSTAGLANDIN E, MFR UNKNOWN