BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VONVENDI MIX2VIAL

    MDR report key: 23251073 · Received October 8, 2025

    Report

    Report Number
    2032282-2025-00018
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    June 19, 2024
    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
    TN, US
    Reporter Occupation
    PHARMACIST
    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. THERE WAS NO TRENDS IDENTIFIED. NO ROOT CAUSE RELATED TO MANUFACTURING WAS IDENTIFIED IN THE COURSE OF THE INVESTIGATION. AS A RESULT, NO ESCALATION, NO DEVIATION, AND NO CORRECTIVE AND /OR PREVENTIVE ACTIONS ARE WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2024 - MS HAD A FOLLOW UP CALL ON FROM ORIGINAL CASE (B)(4). PHARMACIST INDICATED SHE HAD ANOTHER VIAL. LOT TVA22023AA, WHICH WAS HAVING THE SAME INCOMPLETE DILUENT TRANSFER VIA THE MIX 2 DEVICE. SHE INDICATED THAT THE PATIENTS IN BOTH CASES, DID NOT RECEIVE THE FULL DOSE AS ONLY 3 OUT OF THE 4 VIALS COULD BE USED. NEW CASE CREATED TO COVER THE ADDITIONAL LOT PROVIDED TO TAKEDA. PPD PQC INTAKE RECEIVED A CALL ON 26JUN2024: SALES REPRESENTATIVE REACHED OUT TO REPORT A RECONSTITUTION ISSUE WITH VONVENDI. THE CALLER IS REPORTING ON BEHALF OF THE PHARMACIST. LAST WEEK AROUND 6/19/2024 A PATIENT HAD AN ISSUE WITH THE MEDICATION WHICH THE RPH REPORTS THIS HAS BEEN HAPPENING FOR ABOUT A YEAR. IT DOESN'T HAPPEN OFTEN BUT HAS BEEN HAPPENING, IN ANTICIPATION OF THIS OCCURRING THEY KEEP EXTRA MEDICINE, SO PATIENTS DON'T MISSED THEIR DOSES. DISTRIBUTOR, DEA, AND LOT# WERE ALL REQUESTED HOWEVER UNAVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 27 JUNE 2024 - MS TALKED WITH PHARMACIST AND SHE PROVIDED LOT NUMBERS OF TWO SEPARATE VIALS SHE WAS HAVING AN ISSUE WITH. LOTS TVA23016AA AND TVA22023AA BOTH A QTY OF (B)(4) VIAL EACH. SHE INDICATED A SAMPLE WAS NOT AVAILABLE; HOWEVER A PARTIAL / MISSED DOSE HAS BEEN RECORDED AS THE PATIENTS WERE ONLY GETTING 3 OUT OF THE 4 VIALS THEY NEEDED FOR THE DOSE. SHE INDICATED THE MIX 2 DEVICE WAS TRIED EVERY TIME, WHICH RESULTED IN INCOMPLETE DILUENT TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512578 VONVENDI MIX2VIAL MIX2VIAL LHI WEST PHARMA. SERVICES IL, LTD. E727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown