BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWERCTA+ INJECTOR SYSTEM

    MDR report key: 23356696 · Received October 22, 2025

    Report

    Report Number
    23356696
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    May 30, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE IS A PIECE OF PLASTIC FOUND INSIDE BRACCO SYRINGES. [REDACTED], THE BRACCO REPRESENTATIVE WAS NOTIFIED OF THE REGARDING ISSUE. CT SYRINGE WAS PACKAGED AND RETURNED TO THE VENDOR FOR FURTHER INSPECTION AND EVALUATION. MANUFACTURER RESPONSE FOR STERILE DISPOSABLE SYRINGE FOR CT, EMPOWER CTA (PER SITE REPORTER). SEND BACK FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285429 EMPOWERCTA+ INJECTOR SYSTEM INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ BRACCO INJENEERING S.A. 269478

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown