BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM

    MDR report key: 23802823 · Received December 15, 2025

    Report

    Report Number
    1526863-2025-00161
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 3, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    DRS
    UDI-DI
    10351688507853
    PMA / PMN Number
    K172458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION FOR THE COMPLAINT THAT FOLLOWING A PLANNED LINE CHANGE, ATTEMPTS TO DRAW FROM THE NEWLY PLACED KIDS KIT WERE UNSUCCESSFUL, AS IT ONLY COLLECTED AIR BUBBLES. NO VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED SET. DHR OF LOT 6102376 WAS REVIEWED AND IT WAS CONFIRMED THAT NO NON-CONFORMITIES WERE REPORTED DURING PRODUCTION. THE QUALITY INSPECTION FORMS WERE REVIEWED, AND IT WAS OBSERVED THAT NO DEFECTS WERE FOUND, AND THE LOT WAS RELEASED. THE COMPLAINT WAS NOT CONFIRMED THROUGH THE ANALYSIS OF THE RETURNED SAMPLE SINCE THE SYRINGE WAS ABLE TO DRAW WATER WITHOUT AIR BUBBLES DURING THE TESTING OF THE UNIT, THEREFORE THE UNIT WAS FOUND WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A PLANNED LINE CHANGE, ATTEMPTS TO DRAW FROM THE NEWLY PLACED KIDS KIT WERE UNSUCCESSFUL, AS IT ONLY COLLECTED AIR BUBBLES. A NEW LINE WAS PLACED AFTER DELIVERY OF A BAG OF CARRIER FLUID. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789447 MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM ARTERIAL BLOOD SAMPLING KIT DRS ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 6102376 10351688507853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown