BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL

    MDR report key: 24339625 · Received February 13, 2026

    Report

    Report Number
    2032282-2026-00011
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    December 31, 2025
    Report Date
    March 27, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS AVAILABLE FOR RETURN; FURTHER INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    THE TURKISH LOC DID ATTEMPT TO RETURN THE SAMPLE BUT IT WAS HELD UP AT CUSTOMS. PHOTOS WERE PROVIDED, THE INVESTIGATING SITE REVIEWED THE PHOTOS AND DETERMINED THAT THEY WERE SUFFICIENT TO BASE THE INVESTIGATION ON. THEY ALSO NOTED THAT THE THE PRODUCT WAS ASSEMBLED INCORRECTLY BY THE USER AS THE MIX2VIAL DEVICE WAS ATTACHED TO THE VIALS UPSIDE DOWN. THE BLUE PART SHOULD BE PIERCED INTO THE SWFI VIAL AND THE CLEAR PART INTO THE PRODUCT VIAL. IMAGES PROVIDED SHOWED A CINRYZE VIAL (LOT C4B008AB) CONNECTED TO A STERILE WATER FOR INJECTION (SWFI) VIAL (LOT M000690) VIA A MIX2VIAL DEVICE, WITH MINIMAL SOLUTION PRESENT IN THE PRODUCT VIAL AND THE MAJORITY OF DILUENT REMAINING IN THE SWFI VIAL, CONSISTENT WITH THE REPORTED CONDITION; HOWEVER, THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE PHOTOGRAPHS DEMONSTRATED THAT THE MIX2VIAL DEVICE WAS ASSEMBLED INCORRECTLY, WITH THE BLUE END INSERTED INTO THE PRODUCT VIAL RATHER THAN THE SWFI VIAL AND THE CLEAR END INSERTED INTO THE DILUENT VIAL, WHICH WOULD PREVENT PROPER DILUENT TRANSFER. COMPREHENSIVE REVIEWS OF INCOMING INSPECTION, RELEASE DOCUMENTATION, AND RETENTION SAMPLES FOR THE MIX2VIAL DEVICE AND ASSOCIATED DRUG AND DILUENT LOTS IDENTIFIED NO MANUFACTURING ABNORMALITIES OR SPECIFICATION FAILURES, AND RELEASE TESTING CONFIRMED ACCEPTABLE RECONSTITUTION PERFORMANCE FOR THE CINRYZE LOT. THIS WAS THE ONLY COMPLAINT FOR THE LOT RELATED TO DISSOLUTION, NO PATIENT INVOLVEMENT OR ADVERSE CLINICAL OUTCOME WAS REPORTED, AND NO DEVICE OR DRUG MANUFACTURING ROOT CAUSE WAS IDENTIFIED; THEREFORE, THE COMPLAINT WAS NOT CONFIRMED AND NO CORRECTIVE OR PREVENTIVE ACTIONS WERE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE UNIT OF A CINYRZE PRODUCT COULD NOT BE USED DUE TO FAILURE TO DISSOLVE. IT HAS BEEN REPORTED THAT THE PHARMACIST CONTINUED THE PATIENT'S TREATMENT USING A DIFFERENT PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE UNIT OF A CINYRZE PRODUCT COULD NOT BE USED DUE TO FAILURE TO DISSOLVE. IT HAS BEEN REPORTED THAT THE PHARMACIST CONTINUED THE PATIENT'S TREATMENT USING A DIFFERENT PRODUCT. ADDITIONAL INFORMATION RECEIVED 27 JAN 2026: ONLY A FEW DROPS OF DILUENT WERE TRANSFERRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364866 MIX2VIAL TRANSFER DEVICE LHI WEST PHARMA. SERVICES IL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown