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: 24873981 · Received April 14, 2026

    Report

    Report Number
    9615050-2026-00231
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 4, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DEVICE AVAILABLE FOR EVALUATION: NO. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT CANNOT BE REPLICATED OR CONFIRMED. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE THE CUSTOMER REPORTED CONCERNS OF THE DEVICE LEAKING WHEN ADMINISTERING HAZARDOUS AEROSOLIZING MEDICATIONS. IMMEDIATE SOLUTION: 5A WILL USE 120493 - TUBING IV SET PLUM W/.22 MICRON H/P FILTER TO ALIGN WITH BEHRING PRACTICE FOR HAZARDOUS MEDICATIONS REQUIRING A FILTER. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21532 EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 14445250 10887787005919

    Patients

    Seq Age Sex Outcome Treatment
    1