BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    MDR report key: 25075356 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00101
    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
    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 ACTUAL COMPLAINT SAMPLE WAS NOT MADE AVAILABLE, DETAILED INVESTIGATION COULD NOT BE PERFORMED. TWENTY (20) RETENTION SAMPLES FROM SUB-LOT# F2A022AA WHICH ARE REPRESENTATIVE OF THE FILLED PARENT LOT# F2A022 WERE OPTICALLY INSPECTED AND FOUND TO BE SATISFACTORY. FURTHERMORE, A LIGHTHOUSE TEST OF ONE (1) RETENTION SAMPLE (F2A022AA) WAS PERFORMED. IN ADDITION, FIFTY-SIX (56) RETENTION SAMPLES OF SWFI, LOT# K000489 AND ONE (1) RETENTION SAMPLE OF THE BAXJECT DEVICE (LOT 1153209) PACKED TO THE FEIBA LOT# F2A022AF WERE OPTICALLY INSPECTED. NO ABNORMALITIES HAVE BEEN OBSERVED. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF TRANSFER DEVICE BATCH 1153209, ITEM NUMBER 3400691/ BAXJECT II, HI-FLOW, NTD, US, SHOWED THAT THERE WERE NO NONCONFORMITIES, FAILURES, REWORK, OR DEVIATIONS THAT CONTRIBUTED TO THE REPORTED PROBLEM. AS NO ROOT CAUSE WAS IDENTIFIED, NO CORRECTIVE AND / OR PREVENTIVE ACTIONS WERE APPLICABLE. THE COMPLAINT IS NOT CONFIRMED. A REVIEW OF THE MONTHLY REPORT (SEP 2024) FOR FEIBA WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "RECONSTITUTION DIFFICULTY". THE COMPLAINT RATE FOR (B)(6) IS APPROXIMATELY (B)(4) COMPARED TO 2023 (B)(4) AND 2022 (B)(4)).

    Description of Event or Problem · 0

    THE COMPLAINT STATES, "PHARMACY INTERN CALLING TO REPORT A COMPLAINT WITH TWO VIALS OF FEIBA. ONE VIAL IS 20 ML SIZE, AND ONE VIAL IS 50 ML SIZE. WHEN THEY CONNECTED THE STERILE WATER TO THE ACTUAL VIAL IT HAD DEPRESSURIZED, AND THEY WERE NOT ABLE TO GET THE STERILE WATER TO GO INTO THE VIAL TO MIX THE VIAL. IT DID NOT AFFECT THE PATIENT, NOTHING ADVERSE FOR THE PATIENT. INTERN REPORTS, I BELIEVE THEY WERE ABLE TO MIX ANOTHER ONE AND NO DELAY FOR PATIENT. QUERIED FOR SAFETY REPORT, AS VIAL WAS MIXED FOR A PATIENT. HOWEVER, INTERN DID NOT HAVE ANY PATIENT, PRESCRIBER OR PRODUCT INFORMATION OUTSIDE OF LOT/EXP, INFORMATION FOR PQC REPORT. NO FURTHER DETAILS REPORTED OR KNOWN BY INTERN." FOLLOW UP INFORMATION: "(B)(6) 2024: DRUG SAFETY ARGUS REQUEST SENT. FOLLOW UP TO REPORTER AND RESPONSE. ADDITIONAL INFORMATION OBTAINED FROM REPORTER ON 16SEP2024: 1. DID THE PATIENT MISS A DOSE DUE TO THIS OCCURRENCE? ANS: THE PATIENT DID NOT MISS A DOSE. 2. IS THE SAMPLE AVAILABLE FOR RETURN AND IF SO, CAN YOU PROVIDE THE ADDRESS WHERE THE RETURN PACKAGING SHOULD BE SENT? ANS: YES, WE HAVE THE PRODUCTS. (B)(6). DEPARTMENT OF PHARMACY (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287904 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