BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES

    MDR report key: 18737796 · Received February 20, 2024

    Report

    Report Number
    18737796
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    November 30, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    UDI-DI
    17630039300873
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A BRACCO CT FASTLOAD SYRINGE WAS NOTICED TO HAVE BROKEN PIECES IN PACKAGE UPON OPENING. TECH NOTICED WHITE PIECES FROM SYRINGE IN PACKAGING AND DID NOT USE SYRINGE. ALL PARTS AND PACKAGING SAVED. LOT#244589. EXPIRATION 2026-10-10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398148 FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A. 017355 244589 17630039300873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown