BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VONVENDI MIX2VIAL

    MDR report key: 23251028 · Received October 8, 2025

    Report

    Report Number
    2032282-2025-00017
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Report Date
    October 8, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K231071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT CONFIRMED AS NO SAMPLE WAS RECEIVED, AND NO MANUFACTURING ISSUES WITH THE PROCESS, EQUIPMENT, OR MATERIAL WERE IDENTIFIED THAT COULD HAVE ADVERSELY IMPACTED THE QUALITY OF THE PRODUCT. THE LOT WAS MANUFACTURED UTILIZING APPROVED PROCEDURES AND UNDER CGMP GUIDELINES. ALL RELEASE CRITERIA WERE MET. THERE WAS NO TRENDS IDENTIFIED. NO ROOT CAUSE RELATED TO MANUFACTURING WAS IDENTIFIED IN THE COURSE OF THE INVESTIGATION.

    Description of Event or Problem · 0

    RECEIVED AN EMAIL FROM AN HCP. THE EMAIL STATES AS FOLLOWS: "I WANTED TO CONNECT WITH YOU REGARDING OUR PLAN FOR OUR MUTUAL PATIENT (PI REMOVED). IT IS OUR UNDERSTANDING THAT (PI) WILL RECEIVE HER MEDICATION DIRECTLY FROM TAKEDA. I HAVE CC'D THEIR INFORMATION LINE HERE AS WELL. ACCORDING TO THE PACKAGE INSERT, VONVENDI SHOULD NOT BE ADMINISTERED IF THE VACUUM IS LOST DURING PREPARATION WITH THE MIX2 VIAL SYSTEM. WE HAVE SEEN THIS HAPPEN WITH THIS PARTICULAR PATIENT AND WANT TO CLARIFY WHAT THE PATH FORWARD SHOULD BE. WE UNDERSTAND THAT ONE SCHOOL OF THOUGHT IS THAT THE MEDICATION CAN BE DRAWN UP WITH A FILTERED NEEDLE AND THE OTHER SCHOOL OF THOUGHT IS THAT THE MEDICATION SHOULD NOT BE USED. WE WANT TO CLARIFY WHAT OUR PLAN SHOULD BE IF THIS SHOULD HAPPEN WHILE CARING FOR (**PI). I HAVE ATTACHED THE LITERATURE FROM TAKEDA HERE FOR REVIEW AND HAVE CC'D TAKEDA'S INFORMATION LINE SO THAT THEY TOO CAN WEIGH IN. I LOOK FORWARD TO HEARING BACK FROM ALL." ADDITIONAL INFORMATION RECEIVED ON 17 APR 2024 - MS CALLED PHARMACIST. CONFIRMED THERE WAS AN ISSUE WITH THE MIX 2 DEVICE. THE DILUENT DID NOT FULLY TRANSFER. ADDITIONAL INFORMATION RECEIVED ON 03 MAY 2024 - RN NURSE PROVIDED A PICTURE OF THE TWO VIALS. THE SAMPLE IS NOT AVAILABLE TO RETURN. THERE WAS A PARTIAL TRANSFER OF DILUENT. THERE WERE NO MISSED DOSES AND THE PATIENT WAS NOT BEING TREATED FOR AN ACUTE BLEED. ADDITIONAL INFORMATION RECEIVED ON 03 MAY 2024 - MS REACHED BACK OUT TO RN NURSE. TWO LOTS WERE PROVIDED IN THE PHOTO. TVA23003AA AND TVA21013AA. WERE BOTH OF THESE LOTS IMPACTED BY THE PARTIAL DILUENT TRANSFER? OR WAS THERE ONLY ONE OF THESE LOTS IMPACTED? ADDITIONAL INFORMATION RECEIVED ON 03 MAY 2024 - ONLY ONE LOT WAS IMPACTED. LOT WAS TVA21013AA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566977 VONVENDI MIX2VIAL MIX2VIAL LHI WEST PHARMA. SERVICES IL, LTD. E815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown