BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATTEX

    MDR report key: 23476656 · Received November 5, 2025

    Report

    Report Number
    2032282-2025-00033
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Report Date
    December 2, 2025
    Manufacturer
    TAKEDA PHARMACEUTICALS AMERICA, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION FROM THE CONTRACT MANUFACTURING ORGANIZATION.

    Additional Manufacturer Narrative · 0

    NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BOTH BATCHES WERE INSPECTED AND ACCEPTED BASED ON MEETING INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Description of Event or Problem · 0

    FIELD NURSE REPORTS, " PATIENT AND SPOUSE COULDN'T GET THE NEEDLE CAP OFF WITHOUT THE NEEDLE HUB COMING OFF THE SYRINGE, A NEW SYRINGE WAS USED FOR INJECTION AND NO DIFFICULTIES WITH THE NEW SYRINGE OCCURRED." ADVISED TO CALL SPECIALTY PHARMACY.

    Description of Event or Problem · 0

    FIELD NURSE REPORTS, " PATIENT AND SPOUSE COULDN'T GET THE NEEDLE CAP OFF WITHOUT THE NEEDLE HUB COMING OFF THE SYRINGE, A NEW SYRINGE WAS USED FOR INJECTION AND NO DIFFICULTIES WITH THE NEW SYRINGE OCCURRED." ADVISED TO CALL SPECIALTY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2688769 GATTEX SYRINGE FMF TAKEDA PHARMACEUTICALS AMERICA, INC. 4303339 AND 5038159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female