BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    MDR report key: 25075371 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00104
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    February 5, 2025
    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
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 MISASSESSMENT OF REPORTABILITY. THIS REPORT IS BEING SUBMITTED UPON IDENTIFICATION OF THE REPORTING GAP AND CONFIRMATION OF REPORTABILITY. THE SAMPLE WAS RETURNED. THE PRODUCT VIAL HAD AN ENLARGED PENETRATION MARK AND DEFORMATIONS ON THE CRIMP CAP, INDICATING MULTIPLE INSERTION ATTEMPTS WITH FORCE AND MISALIGNMENT. THE DILUENT VIAL ALSO SHOWED AN OFF-CENTERED PENETRATION MARK AND DENTATION MARKS OF VARYING DEPTHS. DESPITE THIS, THE DEVICE WAS UNDAMAGED AND FUNCTIONED CORRECTLY DURING TESTING, TRANSFERRING AND WITHDRAWING DILUENT SUCCESSFULLY WITHOUT LEAKAGE. A REVIEW OF DOCUMENTATION FOR BATCHES: L000598 (DILUENT), 1258899 (BAXJECT DEVICE), AND LOT: F2B017 (FEIBA PRODUCT) REVEALED NO NONCONFORMITIES, FAILURES, REWORK, OR DEVIATIONS. ALL EVALUATIONS WERE COMPLETED, IDENTIFYING NO MANUFACTURING-RELATED ROOT CAUSE. NO CORRECTIVE ACTIONS WERE NEEDED, AND THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE MONTHLY REPORT (MARCH 2025) FOR FEIBA WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "RECONSTITUTION DIFFICULTY". THE COMPLAINT RATE FOR YTD2025 IS APPROXIMATELY (B)(4) COMPARED TO 2024 (B)(4) AND 2023 (B)(4).

    Description of Event or Problem · 0

    THE COMPLAINT STATES, "SCIENTIST CALLED AND STATED THAT ON (B)(6) 2025 WHEN THEY TRIED TO RECONSTITUTE FEIBA 500U FOR ADMINISTRATION FOR A PATIENT, IT WOULD NOT DISPENSE THE PRODUCT. THE CALLER MENTIONED PATIENT DID NOT MISS THEIR DOSE. THE CALLER PROVIDED LOT#: F2B017AN, EXP DATE: 03/31/2026. THE CALLER WAS PROVIDED THE PHONE NUMBER TO TAKEDA CUSTOMER SERVICE FOR CREDIT/REPLACEMENT. THE DEA/NPI WAS REQUESTED BUT UNAVAILABLE." FOLLOW UP INFORMATION: "MARKET SURVEILLANCE (MS) RECEIVED EMAIL FROM CUSTOMER SERVICE 11MAR2025 STATING THE FOLLOWING: THE END CUSTOMER HAS NOT BEEN CONTACTED AT THIS TIME REGARDING SENDING THEIR SAMPLE BACK. CAN SOMEONE REACH OUT TO (B)(6) AT (B)(6)? MS RESPONDED STATING THAT WAS NOT THE ORIGINAL CONTACT PROVIDED WITHIN THE CASE AND THEY HAD BEEN CONTACTED AT DECEMBER. (B)(6) TWICE WITH NO RESPONSE. MS EMAILED NEW CONTACT 12MAR2025. MS RECEIVED RESPONSE FROM NEW CONTACT: (B)(6) - STATING THE FOLLOWING: THE RETURN PACKAGING CAN BE SENT TO THE FOLLOWING ADDRESS: (B)(6) AND PLEASE ADD ATTN: BLOOD BANK. THE VIAL WAS SET UP TO RECONSTITUTE THE LIQUID, BUT NONE OF IT ACTUALLY GOT TRANSFERRED. THE TWO LIQUIDS ARE STILL IN THEIR RESPECTIVE CONTAINERS BUT CONNECTED TOGETHER. WE HAD A PATIENT TAKING MULTIPLE DOSES OF FEIBA THROUGHOUT THE DAY, AND ALL OF THE VIALS EXCEPT FOR THIS ONE WAS ABLE TO BE RECONSTITUTED AND ADMINISTERED TO THE PATIENT. WHEN THE NURSES COULD NOT GET THE VIAL TO RECONSTITUTE, THEY BROUGHT IT BACK DOWN TO US AS IT WAS WITH THE CONTAINERS CONNECTED, AND WE PROVIDED THEM WITH A DIFFERENT VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482838 BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A., INC. GR355742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown