BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW

    MDR report key: 25075336 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00075
    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
    IL, 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 NOT AVAILABLE FOR EVALUATION AND NO PHOTOS PROVIDED. REPORTED DEFECT CANNOT BE VERIFIED. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF DILUENT BATCH L000564, ITEM NUMBER 3500135 / WFI, STER,5.4ML, EP/JP/USP AND 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. ALL INCOMING RELEASE RESULTS AND PARAMETERS MET SPECIFICATIONS. A REVIEW OF THE MONTHLY REPORT ((B)(6) 2024) FOR (B)(4) WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "NO DILUENT TRANSFER". THE COMPLAINT RATE FOR 2024 IS APPROXIMATELY (B)(4)."

    Description of Event or Problem · 0

    (B)(4) - NO DILUENT TRANSFER (LOT M5A003AB). (B)(4) - 4182932 - INCOMPLETE DILUENT TRANSFER (LOT M5A003AB). MEDWATCH REPORT RECEIVED FROM (B)(4) (B)(6) 2023 AT 11:30PM: MCN (ARGUS ID): (B)(4). RECEIVED CALL FROM A HOME HEALTH NURSE WHO STATED THAT WHILE THE 1500UNIT VIAL WORKED FINE, THE 500UNIT VIALS DID NOT WORK. SHE STATED THE DILUENT DID NOT PULL THRU WHEN SHE SPIKED THE DRUG VIAL WITH THE ADAPTER, ONE PULLED A FEW DROPS THRU AND THE OTHER ONE DID NOT PULL ANY DILUENT THRU AT ALL. RN HAD NEEDLES ON HAND AND STATED SHE WOULD DRAW UP DILUENT TO MIX MED AND WOULD GIVE THE DRUG THAT WAY. LOT NUMBER FOR 500 UNIT VIALS L000564; EXPIRATION DATE 04/30/2028. APPEARS PATIENT GETS DRUG FROM MANUFACTURER PROGRAM AND NOT THRU (B)(4) YET. PATIENT DOB: (B)(6)1989.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482836 BAXJECT II HI-FLOW Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female