BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACCO FAST LOAD CT SYRINGE WITH SPIKE FOR EMPOWERCTA

    MDR report key: 17817940 · Received September 25, 2023

    Report

    Report Number
    MW5146140
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BRACCO INJECTOR SYRINGES CRACKING AND/OR EXPLODING DURING INJECTIONS EXPOSING PATIENT AND CLINICIANS TO PLASTIC PROJECTILES AND CONTRAST MEDIA. THIS HAS OCCURRED MORE THAN 50 TIMES SINCE (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097713 BRACCO FAST LOAD CT SYRINGE WITH SPIKE FOR EMPOWERCTA INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other