BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXJECT II HI-FLOW

    MDR report key: 25075326 · Received May 4, 2026

    Report

    Report Number
    2032282-2026-00076
    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
    NC, 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. SAMPLE INVESTIGATION: THE ANALYSIS PERFORMED ON THE UNIT, INDICATES THAT MULTIPLE PENETRATIONS OF BOTH DILUENT AND PRODUCT VIAL STOPPER HAVE OCCURRED. HENCE, "MULTIPLE SPIKING" WAS IDENTIFIED AS THE AS INVESTIGATED CAUSE CODE. 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. REVIEW OF 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 (MAY 2024) FOR ADZYNMA 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

    AN HCP REPORTED AN ADVERSE EVENT FOR ADZYNMA VIA AN EMAIL INQUIRY. THE EMAIL READS AS FOLLOWS, "I WAS MADE AWARE BY ONE OF MY PATIENTS THAT ONE OF THE ADZYNMA VIALS TRANSFER DEVICES THAT WE RECENTLY DISPENSED TO HER MALFUNCTIONED AND WOULD NOT RECONSTITUTE. THE HOME HEALTH RN WAS UNABLE TO ADMINISTER THIS VIAL TO THE PATIENT. WHAT ARE OUR OPTIONS FOR RECEIVING A REPLACEMENT? WHAT ADDITIONAL INFORMATION DO YOU NEED FROM ME?" OUTBOUND CALL 1504 (B)(6) 2024 TO CONFIRM WHERE THE PRODUCT WAS PURCHASED AND TO ASK SAFETY REPORT AND QUALITY REPORT QUESTIONS. THE HOME HEALTH NURSE CAME TO ADMINISTER THE PRODUCT (B)(6) 2024. AVAILABLE FOR RETURN: UNKNOWN. CONSENT TO CONTACT REPORTER? YES. CONSENT TO CONTACT OTHER CONTACT INFO? NO. DOSE (NUMBER): 500 DOSE (UNIT): [[IU]] DOSE NUMBER / UNIT: 500 DOSAGE FORM: IV. FOLLOW-UP TO A PREVIOUS COMPLAINT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287902 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