BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B

    MDR report key: 22789617 · Received August 12, 2025

    Report

    Report Number
    9617594-2025-01665
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619025663
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A PHOTO WAS PROVIDED SHOWING THE PRODUCT IN THE PACKAGING. ONLY THREE (3) SPIROS WERE OBSERVER RATHER THAN THE FOUR (4) THAT WOULD BE PRESENT ON A CH3225. IT IS UNABLE TO BE DETERMINED FROM THE PHOTO WHY THE SET CONFIGURATION DID NOT MATCH THE LIST NUMBER. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE IS UNKNOWN. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION IS PENDING COMPLETION. UPON COMPLETION A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    EVENT OCCURRED REGARDING A SPINNING SPIROS® CLOSED MALE LUER, RED CAP WHERE THEY REPORTED THEY FOUND THE PRODUCT IN THE PACKAGE IS CH3226 INSTEAD OF CH3225. DEVICE WAS NOT USE FOR CHEMO. ONLY ONE (1) DEVICE WAS REPORTED FOR THIS COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT HARM AND THERE WAS NO DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350299 14" (36 CM) APPX 8.0 ML, QUINFUSE ADD-ON SET W/4 SPIROS¿, BAG SPIKE, 5 CLAMPS (B CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14045180 00840619025663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown