BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW

    MDR report key: 25075341 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00073
    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
    MN, US
    Reporter Occupation
    NURSE
    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. RETENTION SAMPLES: LOT NUMBER M5A004AB. INTERNAL MANUFACTURING INVESTIGATION WAS PERFORMED AT VIENNA. RETENTION SAMPLES WERE EVALUATED. PHYSICAL RETENTION SAMPLES FROM ADZYNMA SUB-LOT# M5A004AB ARE NOT AVAILABLE. HOWEVER, ONE HUNDRED AND EIGHT (108) RETENTION SAMPLES FROM SUB-LOT# M5A004AA WHICH ARE REPRESENTATIVE FOR THE FILLED PARENT LOT# M5A004 WERE OPTICALLY INSPECTED AND FOUND TO BE SATISFACTORY. FURTHERMORE, A LIGHTHOUSE TEST OF ONE (1) RETENTION SAMPLE (M5A004AA) WAS PERFORMED. NO ABNORMALITIES HAVE BEEN OBSERVED. IN ADDITION, TWO HUNDRED SIXTEEN (216) RETENTION SAMPLES OF SWFI, LOT# L000551 AND ONE (1) RETENTION SAMPLE OF BAXJECT, LOT# 1153209 PACKED TO ADZYNMA LOT# M5A004AB WERE OPTICALLY INSPECTED. THE INSPECTED/TESTED SAMPLES WERE COMPLIANT WITH THE REQUIREMENTS. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF 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 ADZYNMA WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "INCOMPLETE DILUENT TRANSFER". THE COMPLAINT RATE FOR 2024 IS APPROXIMATELY (B)(4)."

    Description of Event or Problem · 0

    REPORT RECEIVED FROM CUSTOMER SERVICE ON 20MAY2024: PER NURSE: "I WANTED TO REACH OUT TO LET YOU KNOW THAT WE HAD A NEW PATIENT IN THE SUITES TODAY FOR FIRST DOSE OF ADZYMNA. THE NURSE WHO WAS MIXING THE MED HAD SOME DIFFICULTY WITH THE BAXJECT DEVICE AND COULDN'T GET ONE OF THE VIALS TO WORK. (THERE WERE 3 VIALS: 2 WORKED FINE.) THEN THERE WAS AN ADDITIONAL PROBLEM WITH DRAWING UP THROUGH THE BAXJECT ON THE SIDE. SHE ENDED UP USING A SYRINGE AND NEEDLE TO DO THE COMPOUNDING AND DRAWING UP OF THE MED. JUST WANTED TO CHECK IN WITH YOU TO LET YOU KNOW AND TO MAKE SURE THAT THIS PRACTICE IS ACCEPTABLE. OUR NURSES ARE INFUSION EXPERTS AND MIX ALL KINDS OF DRUGS, SO WE FELT IT WAS A SAFE SOLUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112464 BAXJECT II HI-FLOW Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown