BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    MDR report key: 25075359 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00103
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Report Date
    May 4, 2026
    Manufacturer
    TAKEDA PHARMACEUTICALS U.S.A., INC.
    Product Code
    LHI
    PMA / PMN Number
    K092318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS SUBMITTED FOLLOWING A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED UNDER CAPA PR 5560509. THE EVENT MET MDR REPORTABILITY CRITERIA BUT WAS NOT REPORTED WITHIN THE REQUIRED TIMEFRAME DUE TO AN INITIAL MIS-ASSESSMENT OF REPORTABILITY. THIS REPORT IS BEING SUBMITTED UPON IDENTIFICATION OF THE REPORTING GAP AND CONFIRMATION OF REPORTABILITY. PHYSICAL SAMPLE WAS NOT RETURNED HOWEVER, PHOTOS WERE PROVIDED. DUE TO THE QUALITY OF THE PICTURES THE BATCH NUMBER CANNOT BE IDENTIFIED. TWENTY-EIGHT (28) RETENTION SAMPLES FROM FEIBA LOT F2B017AA, ONE HUNDRED TWENTY-TWO (122) RETENTION SAMPLES FROM SWFI LOT L000598 AND ONE (1) RETENTION SAMPLE OF THE BAXJECT DEVICE (LOT 1258899) PACKED TO LOT F2B017AN WERE OPTICALLY INSPECTED. FURTHERMORE, A LIGHTHOUSE TEST OF ONE (1) RETENTION SAMPLE (F2B017AA) WAS PERFORMED. THE INSPECTED SAMPLES WERE COMPLIANT WITH THE REQUIREMENTS; NO ABNORMALITIES HAVE BEEN OBSERVED. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION SWFI OF BATCH L000598, ITEM NUMBER 3500052 / STERILE WFI EP, USP 10ML, NEW FILLING LINE, AND OF DEVICE BATCH 1258899, ITEM NUMBER 3400769 / BAXJECT II,HI-FLOW, NTD,US SHOWED THAT THERE WERE NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT CONTRIBUTED TO THE REPORTED PROBLEM. A LOT HISTORY REVIEW WAS PERFORMED ON ALL FINISHED PRODUCT LOTS, THAT WERE PACKED WITH THE SAME DEVICE BAXJECT LOT 1258899. NO ROOT CAUSE WAS IDENTIFIED, NO CORRECTIVE AND / OR PREVENTIVE ACTIONS WERE APPLICABLE. THE COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE MONTHLY REPORT (DECEMBER 2024) FOR FEIBA WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "RECONSTITUTION DIFFICULTY". THE COMPLAINT RATE FOR YTD2024 IS APPROXIMATELY (B)(4) COMPARED TO 2022 (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT STATES, "PER REPORT: PROVIDER CALLED TO LET US KNOW THEY WERE HAVING PROBLEMS WITH THE VACUUM PART OF THE PRODUCT." FOLLOW UP INFORMATION: "13DEC2024: PPD PQC INTAKE TEAM RECEIVED A FOLLOW-UP EMAIL FOR (B)(6). (MS). UPDATED REPORTERS' INFORMATION AND ADDED THE LOT# F2B017AN. 10JAN2025: MS RECEIVED ADDITIONAL INFORMATION FROM REPORTER · WAS DOSE MISSED DUE TO THIS OCCURRENCE? NO · HOW MUCH WATER TRANSFERRED? NONE? SOME? PARTIAL · IS THE SAMPLE AVAILABLE FOR RETURN AND IF SO, CAN YOU PROVIDE THE ADDRESS WHERE THE RETURN PACKAGING CAN BE SENT? YES, ALSO SHARING PHOTOS OF PRODUCT (B)(6) HOSPITAL. · PLEASE PROVIDE ANY ADDITIONAL DETAILS PERTAINING TO THIS INCIDENT. PHARMACY TECHNICIAN & PHARMACIST FOLLOWING MFG RECONSTITUTION INSTRUCTIONS COULD NOT GET THE DILUENT TO FLOW INTO THE MEDICATION VIALS. THEY NEEDED TO USE ADDITIONAL PRODUCT TO MAKE THE ORDERED DOSE. VIALS WERE STORED AT ROOM TEMPERATURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288025 BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown