BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD CTA DUAL SYRINGE PACK CT CONTRAST SYRINGE

    MDR report key: 20159059 · Received September 5, 2024

    Report

    Report Number
    MW5159256
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 29, 2024
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OUR IMAGING DEPARTMENT REPORTED THAT ON TWO SEPARATE INSTANCES, WHILE ATTEMPTING TO DRAW UP CONTRAST MATERIAL IN THE BRACCO CT (COMPUTED TOMOGRAPHY) CONTRAST SYRINGE "EMPOWER CTA FASTLOAD CTA", THE MATERIAL WOULD NOT DRAW UP. STAFF THEN NOTICED A SMALL CRACK IN THE SYRINGE. SYRINGE WAS NOT USED AND IT WAS REPLACED WITH PROPER FUNCTIONING SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1588037 FASTLOAD CTA DUAL SYRINGE PACK CT CONTRAST SYRINGE INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown