BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX 4-WAY STOPCOCK EXTENSION SET

    MDR report key: 23167870 · Received September 29, 2025

    Report

    Report Number
    3012307300-2025-11018
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 4, 2025
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPK
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    TWO PICTURES WERE PROVIDED BY CUSTOMER RELATED TO THE FAILURE MODE REPORTED IN THIS COMPLAINT THAT TUBING BREAKING OFF A NON-MODULAR CONNECTION AND RECEIVED 105 SEALED SAMPLES OF MX43860 LOT 6113680, 6 SEALED SAMPLES OF MX43860 LOT 6095830 AND 9 SEALED SAMPLES OF MX43860 LOT 6082808. DURING LOT HISTORY REVIEW THERE WERE NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT. DURING VISUAL INSPECTION, ALL THE SAMPLES PASSED SINCE NO FAILURES OR ANOMALIES WERE DETECTED DURING THE INSPECTION. THE PICTURES PROVIDED BY CUSTOMER WERE ANALYZED AND IT WAS CONFIRMED THAT TUBE P/N: 105C-06 WAS DETACHED FROM PN: A521T-105G2. THE REPORTED CONDITION WAS CAUSED BY THE TUBE, P/N 105C-06, HAVING AN OUT-OF-SPECIFICATION OUTSIDE DIAMETER, WHICH OCCURRED DURING THE SUPPLIER'S MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD THREE INSTANCES REPORTED OF THE TUBING BREAKING OFF A NON-MODULAR CONNECTION. ONE INSTANCE CAUSED A PATIENT TO LOSE A SIGNIFICANT AMOUNT OF BLOOD FROM THEIR ART LINE. THE EVENT OCCURRED DURING USE ON PATIENT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772302 MEDEX 4-WAY STOPCOCK EXTENSION SET TUBING, FLUID DELIVERY FPK ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 6113680

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown