BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK

    MDR report key: 23835518 · Received December 17, 2025

    Report

    Report Number
    9615050-2025-00622
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 20, 2025
    Report Date
    January 21, 2026
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005919
    PMA / PMN Number
    K151969
    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

    H10 - ADDITIONAL RELATED REPORT NUMBERS. 9615050-2025-00625-00. 9615050-2025-00624-00. SIXTEEN NEW EXTENSION SETS WERE RECEIVED FOR EVALUATION ON 12/29/2025. AS RECEIVED, NO DAMAGE OR ANOMALIES WERE NOTED. ONE PHOTO WAS RECEIVED FOR REVIEW ALSO AND IT SHOWED A SET WITH LEAKAGE AT THE INLINE FILTER. THE FILTER ON THE SIXTEEN NEW SETS WERE LEAK TESTED AND NO LEAKAGE WAS OBSERVED ON ANY OF THEM. THE REPORTED COMPLAINT OF LEAKAGE AT THE FILTER CANNOT BE REPLICATED BUT CAN BE CONFIRMED FOR ONE SET BASED ON THE CUSTOMER PROVIDED PHOTO. THE PROBABLE CAUSE CANNOT BE DETERMINED WITHOUT THE RETURN OF THE REPORTED SET. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED AN EXTENSION SET, 17INCH, 0.2 MICRON FILTER, CLAVE (TM), Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THE DEVICE HAS A LEAKING ISSUE DURING INFUSION OF MIXED CHEMOTHERAPY (DOXORUBICIN, ETOPOSIDE AND VINCRISTINE). THERE WAS PATIENT INVOLVEMENT, NO HARM AND DID CAUSE A DELAY IN THERAPY. THIS REPORT CAPTURES SECOND OF FOUR INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230444 EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 14338083 10887787005919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DOXORUBICIN, UNK MFR| ETOPOSIDE, UNK MFR| VINCRISTINE, UNK MFR