BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL TRANSFER DEVICE

    MDR report key: 24339645 · Received February 13, 2026

    Report

    Report Number
    2032282-2026-00012
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Report Date
    April 17, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE CONSISTED OF A MIX2VIAL/CINRYZE UNIT CORRECTLY ASSEMBLED WITH DILUENT AND PRODUCT VIAL. AS EVIDENCED BY THE REPORT AN EXAMINATION OF THE SAMPLE AS RECEIVED AND AFTER DISASSEMBLING PROVIDED INDICATIONS THAT THE RECONSTITUTION STEPS WERE MOST LIKELY NOT PERFORMED AS RECOMMENDED IN THE USER INSTRUCTIONS. A FUNCTIONALITY TEST WAS CARRIED OUT WITH NO ISSUE. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    SAMPLE IS AVAILABLE FOR RETURN, FURTHER INVESTIGATION IS PENDING.

    Description of Event or Problem · 0

    E-MAIL READS: "MY PHARMACY RECENTLY RECEIVED AND DISPENSED A VIAL OF CINRYZE TO OUR NURSING STAFF. UNFORTUNATELY WHEN THE RN CONNECTED THE VIAL AND THE STERILE WATER USING THE PROVIDED DEVICE THE VACUUM TO MIX THE PRODUCT DID NOT WORK. FAULTY VIAL AND DEVICE I BELIEVE. IS THERE A WAY I CAN GO ABOUT RECEIVING A REPLACEMENT VIAL?" AN OUTBOUND CALL WAS PLACED TO THE REQUESTOR TO OBTAIN ADDITIONAL DETAILS. UNABLE TO REACH REQUESTOR AND A VOICEMAIL WAS LEFT TO RETURN OUR CALL TO TAKEDA MEDICAL INFORMATION. ADDITIONAL INFORMATION RECEIVED ON 21-JAN-2026: WAS DOSE MISSED DUE TO THIS OCCURRENCE? NO. PHARMACY HAD SPARE STOCK. WAS THERE ANY INJURY OR MEDICAL INTERVENTION NEEDED AS OF RESULT OF THIS INCIDENT? NO. LOT/EXP FOR CINRYZE, DILUENT. CINRYZE: C4C001AD, EXP 1/31/28; DILUENT: N000744, 12/31/29. WAS THE DILUENT VIAL PLACED ON A FLAT SURFACE AS INSTRUCTED? YES. WAS THE BLUE END INSERTED INTO THE DILUENT VIAL STRAIGHT DOWN WITH THE DEVICE POSITIONED COMPLETELY VERTICAL? YES. DID THE SPIKE PENETRATE THE CENTER OF THE DILUENT STOPPER (OR WAS IT OFF-CENTER)? YES. WAS THE CLEAR END INSERTED STRAIGHT DOWN, DEVICE COMPLETELY VERTICAL, THROUGH THE CENTER OF THE CINRYZE STOPPER? YES. AFTER CONNECTING, WAS THERE MOVEMENT OF FLUID (DRIP, PARTIAL TRANSFER, NO TRANSFER)?NO DID THEY NOTICE HISSING, LOSS OF SEAL, OR LIQUID ESCAPING AT THE CONNECTION? NO. WAS THE MIX2VIAL FULLY ASSEMBLED AND LOCKED, OR DID IT FEEL LOOSE/WOBBLY? FULLY ASSEMBLED. IS THE SAMPLE AVAILABLE FOR RETURN AND IF SO, CAN YOU PROVIDE THE ADDRESS, CONTACT NAME AND PHONE NUMBER WHERE THE RETURN PACKAGING CAN BE SENT? YES. (B)(6), (B)(6). (B)(6).

    Description of Event or Problem · 0

    E-MAIL READS: "MY PHARMACY RECENTLY RECEIVED AND DISPENSED A VIAL OF CINRYZE TO OUR NURSING STAFF. UNFORTUNATELY, WHEN THE RN CONNECTED THE VIAL AND THE STERILE WATER USING THE PROVIDED DEVICE THE VACUUM TO MIX THE PRODUCT DID NOT WORK. FAULTY VIAL AND DEVICE I BELIEVE. IS THERE A WAY I CAN GO ABOUT RECEIVING A REPLACEMENT VIAL?" AN OUTBOUND CALL WAS PLACED TO THE REQUESTOR TO OBTAIN ADDITIONAL DETAILS. UNABLE TO REACH REQUESTOR AND A VOICEMAIL WAS LEFT TO RETURN OUR CALL TO TAKEDA MEDICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392081 MIX2VIAL TRANSFER DEVICE TRANSFER SET LHI WEST PHARMA. SERVICES IL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown