BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRAZYR

    MDR report key: 23503810 · Received November 7, 2025

    Report

    Report Number
    2032282-2025-00039
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Report Date
    November 7, 2025
    Manufacturer
    TAKEDA PHARMACEUTICALS USA INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLAINT SAMPLE EXAMINATION RESULTS THE DEFECT COULD NOT BE CONFIRMED. THE BATCH WAS MANUFACTURED PER SPECIFICATIONS AND RELEASED. THE INVESTIGATION REVEALED NO INDICATION OF A ROOT CAUSE RELATED TO CONTRACT MANUFACTURING ORGANIZATION'S OR THE SUPPLIER'S MANUFACTURING PROCESSES. THERE WAS NO IMPACT ON THE BATCH QUALITY. THE RETAINED SAMPLES WERE UNREMARKABLE; NO ANOMALIES WERE FOUND. NO DEVIATION AND NO FURTHER COMPLAINTS WERE DOCUMENTED FOR THE IMPACTED BATCH. THE PRIMARY PACKAGING MATERIALS WERE WITHOUT ANY DEFECTS. THE NEEDLE FROM THE SAMPLE HAD A STABLE FIT ON THE SYRINGE CONE. THE FUNCTIONALITY OF THE SYRINGE COULD BE PROVED. NO LEAKAGE OCCURRED. HOWEVER, IT WAS DETERMINED BY PRIMARY PACKAGING MATERIAL EXPERTS THAT OVER-TIGHTENING THE NEEDLE COULD LEAD TO THE LUER LOCK ADAPTER BEING UNSCREWED FROM THE SYRINGE CONE. THIS INDICATED MOST PROBABLY IMPROPER HANDLING AS THE ROOT CAUSE FOR THE CURRENT COMPLAINT. RELATED REPORT (MFR: 2032282-2025-00038) WILL CAPTURE LOT 565771, (EXPIRATION DATE: 04 2026).

    Description of Event or Problem · 0

    WHEN THE PATIENT ATTEMPTED SELF-ADMINISTRATION, S/HE ATTACHED THE INJECTION NEEDLE TO THE FIRAZYR DEVICE. HOWEVER, WHEN TRYING TO ADMINISTER THE INJECTION, THE NEEDLE DETACHED FROM THE DEVICE AND THE MEDICATION COULD NOT BE ADMINISTERED. THIS ISSUE OCCURRED WITH TWO DEVICES . AFFECTED LOT: 1) 560434 (EXPIRATION DATE: 10 2025) - BULK BATCH TFXE03J. HAD A REQUEST FOR THE CAUSE OF WHY THE NEEDLES DETACHED ONLY WITH THE TWO DEVICES. THE PATIENT HAS ALREADY COMPLETED DOSING WITH AN ALTERNATIVE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781720 FIRAZYR SYRINGE FMF TAKEDA PHARMACEUTICALS USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown