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: 23764914 · Received December 10, 2025

    Report

    Report Number
    9617594-2025-02284
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 7, 2026
    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

    A PHOTO WAS RETURNED SHOWING THE DRIP CHAMBER BAG SPIKE INSERTED INTO THE DRY SPIKE ADAPTOR. THERE WAS NO LEAKAGE OBSERVED IN THE PHOTO PROVIDED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW WAS PERFORMED, AND NO NONCONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT. UPDATED INFORMATION IN D9.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. ADDITIONAL REPORTER INFORMATION: (B)(6).

    Description of Event or Problem · 0

    AN EVENT INVOLVED A 14 APPX 8.0 ML, QUINFUSE ADD-ON SET, BAG SPIKE, 5 CLAMPS, DRY SPIKE ADAPTER REPORTED LEAKAGE FROM THE END OF ADMINISTRATION SET. EVENT WAS NOTED DURING INFUSION. AN UNKNOWN CHEMO DRUG WAS INVOLVED IN THE EVENT. THERE WAS NO BLEED BACK REPORTED. THE PRODUCT IS NOT A BIOHAZARD, AND THE DEVICE WAS NOT REPROCESSED/RE STERILIZED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM. THERE WAS NO DELAY IN CRITICAL THERAPY. THIS REPORT CAPTURES TEN OCCURRENCES INVOLVING THE SAME DEVICE MODEL. NO ADDITIONAL IDENTIFYING INFORMATION WAS AVAILABLE FOR ANY OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876121 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. 14124124 00840619025663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN CHEMO DRUG, UNK MFR