BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL TRANSFER DEVICE

    MDR report key: 23248984 · Received October 8, 2025

    Report

    Report Number
    2032282-2025-00020
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Report Date
    October 9, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K231071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SCIENCES PERSONNEL ANALYZED THE VONVENDI PRODUCT VIAL, DILUENT VIAL, AND MIX2VIAL DEVICE ASSOCIATED. DURING INSPECTION, NO ABNORMALITIES WERE OBSERVED ON ANY OF THE SAMPLE COMPONENTS; THE SAMPLE WAS FOUND TO BE IN SATISFACTORY CONDITION. A REVIEW WAS PERFORMED OF PRODUCT VIAL FOR VACUUM ISSUES, AND NO VIALS WERE REJECTED DURING INSPECTION.THE MIX2VIAL DEVICE WAS TESTED AND OPERATED AS INTENDED. AS A RESULT, ISSUE UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 0

    PATIENT REPORTED, "I SELF-ADMINISTER VONVENDI (VONWILLEBRAND FACTOR CONCENTRATE). THE PROCEDURE INVOLVES USING THE MIX2VIAL DEVICE TO TRANSFER STERILE WATER FROM A VIAL INTO A VIAL OF LYOPHILIZED POWDER. THE VACUUM IN THE POWDER VIAL IS CRITICAL TO THE TRANSFER. I'VE HAD NUMEROUS FAILURES WITH THIS MIXING DEVICE. WHAT HAPPENS IS AIR LEAKS INTO THE SYSTEM AND NOT ALL THE WATER TRANSFERS. SOMETIMES IT WASTES A VIAL THAT COSTS ABOUT $5000. OVER THE YEARS I'VE BEEN SELF-ADMINISTERING VON VENDI, ABOUT ONE OUT OF TEN DOSES IS AFFECTED BY FAILURES LIKE THIS. I HAVE DILIGENTLY TRIED TO IMPROVE MY TECHNIQUE. I HAVE READ AND REREAD THE INSTRUCTIONS AND I'M FOLLOWING THEM WELL. I PUT THE WATER VIAL ON A HARD SURFACE, AND I PRESS STRAIGHT DOWN. I DO MY BEST TO KEEP THE VIALS IN ALIGNMENT, BUT THAT IS DIFFICULT BECAUSE OF THE WAY THE CLAWS OF THE VIAL RELEASE ON ONE SIDE BEFORE THE OTHER, CAUSING A TIPPING FORCE. I DO MY BEST TO RESIST THAT TIPPING FORCE, BUT SOMETIMES IT IS NOT POSSIBLE TO KEEP THE VIALS IN COMPLETE ALIGNMENT. THIS IS A DEFECT OF DESIGN. YOU SHOULD TRY ONE AND YOU'LL SEE WHAT I MEAN. THE OTHER FAILURE HAPPENS WHEN AIR LEAKS INTO THE SYSTEM THAT IS SUPPOSED TO BE SEALED BY DESIGN. STERILITY IN IV MEDICATION IS ACCOMPLISHED BY USING A CLOSED SYSTEM. THE MIX2VIAL SOMETIMES LETS AIR LEAK INTO THE SYSTEM, AND NOT ALL OF THE WATER TRANSFERS, BECAUSE THE VACUUM IN THE POWDER VIAL IS EXHAUSTED BY THE LEAKING AIR. WHEN THE MIX2VIAL FAILS, I TRY TO USE A BLUNT TRANSFER NEEDLE TO COMPLETE THE TRANSFER. THIS, TOO, IS A LEAKY PROCESS. SOMETIMES THE WATER LEAKS AND THAT IS ANOTHER BREACH OF A CLOSED, STERILE SYSTEM. ONCE WHEN THE VACUUM WAS LOST, I TRIED WARMING THE WATER VIAL WITH MY HAND TO PUSH THE WATER INTO THE POWDER VIAL. IT LEAKED OUT FROM THE MIX2VIAL INSTEAD. THAT WAS A WASTED VIAL. IN MY CAREER I TESTED AIRPLANES, I USE TERMS LIKE, "DEFECT," AND "FAILURE," IN THEIR SPECIFIC PRODUCT TESTING MEANINGS. DEFECTS ARE SHORTCOMINGS IN DESIGN. FAILURE ARE THE ADVERSE EVENTS CAUSED BY DEFECTS. THERE IS A DEFECT IN THE MIX2VIAL THAT LEADS TO THESE FAILURES, AND THE FAILURES ARE NOT RARE. I HAVE BEGUN LOGGING THEM. I ESTIMATE THAT I EXPERIENCE A FAILURE IN ABOUT ONE IN TEN DOSES. EACH DOSE IS THREE VIALS, SO THERE IS ABOUT A 3% FAILURE RATE THAT I AM EXPERIENCING. AFTER A FEW MORE MONTHS OF LOGGING, I'LL HAVE A RECORD AND A MORE ACCURATE ESTIMATE. MY PHARMACY HAS BEEN VERY SUPPORTIVE. THEY GET ME REPLACEMENTS FOR THE WASTED VIALS AT NO COST. I WAS HOPING THAT THE VONVENDI MANUFACTURER WOULD NOTICE. AFTER FIVE YEARS, I DECIDED TO DECLARE THESE MIX2VIAL FAILURES AS ADVERSE EVENTS TO TAKEDA, AND THIS MESSAGE IS RESULTING FROM THEIR INVESTIGATION. MIX2VIAL FAILURES DELAY MY TREATMENT. THE LEAKS THREATEN TO CONTAMINATE THE STERILE MEDICINE. I HAVE TO TRAVEL WITH EXTRA VIALS SO I WON'T UNDERDOSE IF I WASTE A VIAL TO A MIX2VIAL FAILURE ON TRAVEL. I HAVE TO LOG THE FAILURES. I HAVE TO REPLACE EXPENSIVE MEDICINE, THAT IS SPOILED BY WHEN MIX2VIAL FAILS. I ASKED THE VONVENDI MANUFACTURER TO GIVE ME A PLAN AND A TIMEFRAME FOR RESOLVING THIS DEFECT. I HAVE AN ADVERSE EVENT REPORT IN PROGRESS WITH THE VONVENDI MANUFACTURER. MY PHARMACY IS SUPPORTING MY EFFORT TO GET THIS DEVICE UPDATED. THAT IS HOW I WAS REFERRED TO YOU. IT IS UNFORTUNATE IF I AM THE ONLY PATIENT THAT WILL DEMAND A DEVICE THAT HAS A LOW FAILURE RATE. MANY PATIENTS DON'T UNDERSTAND ABOUT HOW TO COMPLAIN ABOUT PROBLEMS IN MEDICINE, BUT I DO AND I HAVE. A LOW RATE WOULD BE MUCH LESS THAN 1%. PATIENT REPORTS THAT THERE IS "ABOUT A 3% FAILURE RATE" WITH HIS VIALS BUT DID NOT REPORT THE EXACT NUMBER OF VIALS THAT HAVE FAILED. NUMBER OF UNITS IMPACTED WAS NOT REPORTED. MEDICATION DOSE WAS NOT REPORTED." ON 30 SEP 2024, FOLLOW UP INFORMATION WAS RECEIVED. "· WAS THERE ANY INJURY OR MEDICAL INTERVENTION NEEDED AS OF RESULT OF THIS ISSUE? IF YES, PLEASE EXPLAIN. PRESENTLY I AM UNINJURED BY THE ISSUE. · DID YOU MISS A DOSE AS A RESULT OF THIS ISSUE? SO FAR IT HAS NOT AFFECTED MY DOSING, AS I CAN TEMPORARILY REPLACE A SPOILED VIAL FROM MY STOCK. STILL, I TRAVEL WITH AN EXTRA VIAL AS A PRECAUTION. · PLEASE PROVIDE LOT NUMBER(S) IF AVAILABLE. THE LATEST SPOILED VIAL WAS LOT NUMBER TVA24003AA. I AM MOVING AND MY TREATMENT LOGS ARE PACKED AWAY. IF YOU LIKE, I CAN GIVE YOU MORE LOT NUMBERS IN A FEW DAYS. I RETURNED ALL PRIOR SPOILED VIALS, WITH NOTES ABOUT THE FAILURES, VIA THE WASHINGTON CENTER FOR BLEEDING DISORDERS (WACBD). WHEN I HAVE A SPOILED VIAL, I WAIT UNTIL MY NEXT MONTHLY PICKUP OF VONVENDI TO REPORT THE FAILURE TO WACBD AND RETURN THE VIAL. · HOW MUCH WATER TRANSFERRED INTO THE PRODUCT VIAL DURING RECONSTITUTION; NONE, PARTIAL, OR ALL? ALMOST ALWAYS, IT IS A PARTIAL TRANSFER. AIR LEAKS INTO THE SYSTEM AND THE VACUUM IS PREMATURELY EXHAUSTED. · ARE SAMPLE(S) AVAILABLE FOR EVALUATION? IF SO, PLEASE PROVIDE ADDRESS TO SHIP RETURN SAMPLE PACKAGING. I PRESENTLY HAVE AN UNRETURNED VIAL. MY WACBD PHARMACY HAS RETURNED ALL PREVIOUSLY SPOILED VIALS AND PROVIDED ME WITH A REPLACEMENT EACH TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481778 MIX2VIAL TRANSFER DEVICE Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD. H799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male