BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATTEX

    MDR report key: 23268538 · Received October 10, 2025

    Report

    Report Number
    2032282-2025-00024
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Report Date
    November 7, 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

    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. BATCH WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Additional Manufacturer Narrative · 0

    SAMPLE INVESTIGATION PENDING FROM CONTRACT MANUFACTURING ORGANIZATION. SECTION G4: NDA# 203441. SECTION G8: MANUFACTURER REPORT NUMBER (B)(4).

    Description of Event or Problem · 0

    THE FIELD NURSE REPORTS ON BEHALF OF PATIENT, "THE NEEDLE IS DETACHING FROM THE DOSING SYRINGE: HAPPENED ABOUT FIVE TIMES YESTERDAY AND OCCURRED ONCE TODAY."

    Description of Event or Problem · 0

    THE FIELD NURSE REPORTS ON BEHALF OF PATIENT, "THE NEEDLE IS DETACHING FROM THE DOSING SYRINGE: HAPPENED ABOUT FIVE TIMES YESTERDAY AND OCCURRED ONCE TODAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060002 GATTEX SYRINGE FMF TAKEDA PHARMACEUTICALS AMERICA, INC 4303339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown