BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRAZYR

    MDR report key: 18727764 · Received February 16, 2024

    Report

    Report Number
    2032282-2024-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 15, 2024
    Manufacturer
    TAKEDA PHARMACEUTICALS AMERICA, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ISSUE CANNOT BE CONFIRMED BECAUSE SAMPLE WAS NOT RETURNED. INVESTIGATION REPORT FROM VETTER (CMO) INCLUDES, A QUERY WAS PERFORMED WITHIN THE VETTER QUALITY MANAGEMENT SYSTEM REGARDING ANY NONCONFORMITIES FOR THE AFFECTED BATCH. NO DEVIATIONS AND NO FURTHER COMPLAINTS WERE DOCUMENTED. ADDITIONALLY, THE FIRAZYR BATCHES MANUFACTURED BEFORE AND AFTER THE IMPACTED BATCH WERE INCLUDED INTO THE QUERY. BASED ON THESE RESULTS, THERE IS NO TREND INDICATED REGARDING SIMILAR COMPLAINTS FOR THE PRODUCT FIRAZYR. NO POSSIBLE ROOT CAUSE IS PRESENT DURING MANUFACTURING AT VETTER , NO CAPA WAS INITIATED. BASED ON THE RESULTS OF THE CONDUCTED INVESTIGATION, THERE IS NO IMPACT ON THE QUALITY OF THE IMPACTED BATCH. DHL (CMO) ALSO CONDUCTED INVESTIGATION, A ROOT CAUSE WAS NOT IDENTIFIED FOR THE REPORTED DEFECT. IT IS UNLIKELY THAT A DEFECT OF THIS NATURE WOULD OCCUR DURING THE PACKAGING PROCESS AT DHL. THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT RELATED TO THIS DEFECT. NO LOT TREND HAS BEEN ESTABLISHED.

    Additional Manufacturer Narrative · 0

    A SAMPLE HAS BEEN REQUESTED TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    PATIENT REPORTED "I HAD TO TAKE FIRAZYR EARLY THIS MORNING. I WAS ONLY ABLE TO INJECT HALF OF THE DOSE FOR SOME REASON AND THEN IT FELT LIKE THE PLUNGER WAS RESISTING."

    Description of Event or Problem · 0

    PATIENT REPORTED "I HAD TO TAKE FIRAZYR EARLY THIS MORNING. I WAS ONLY ABLE TO INJECT HALF OF THE DOSE FOR SOME REASON AND THEN IT FELT LIKE THE PLUNGER WAS RESISTING? I HAVE NO OTHER DOSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085638 FIRAZYR SYRINGE, PISTON FMF TAKEDA PHARMACEUTICALS AMERICA, INC. TFVJ09A15

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female TAKHZYRO