BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT CONTRAST INJECTOR SYRINGES

    MDR report key: 21114712 · Received January 8, 2025

    Report

    Report Number
    MW5164484
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    November 11, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BRACCO INJENEERING S.A./ BRACCO INJENEERING
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS IS A PROBLEM THROUGHOUT THE SSM SYSTEM. THE BRACCO INJECTORS WE USE FOR CAT SCAN ARE SUBJECT TO CONTAMINATION WITH EVERY PATIENT. BRACCO SENT REPRESENTATIVES TO(B)(6) HOSPITAL FOR ANOTHER FAILING ISSUE WE WERE HAVING WITH THEIR INJECTORS. EVERY TECHNOLOGIST THEY TALKED TO TOLD THEM THEIR SYRINGE KITS CAN'T BE USED IN A STERILE FASHION AND EVERY PATIENT THAT HAS A CT SCAN WITH CONTRAST IS SUBJECT TO CONTAMINATION. THE SPIKES WITH THE KITS DON'T HAVE A CAP ON THEM AND ARE IMPOSSIBLE TO INSTALL WITHOUT CONTAMINATING THE SPIKES. A SIMPLE RESOLUTION WOULD HAVE BEEN TO ORDER THE SPIKES WITH CAPS ON THEM. THAT IS HOW OUR OTHER SYRINGE KITS FROM MEDRAD CAME WITH A CAPPED SPIKE. I HAVE PICTURES OF THE SYRINGE KITS, LET ME KNOW IF YOU'D LIKE THEM. AT SOME POINT A PATIENT WILL HAVE ISSUES BECAUSE IT ISN'T POSSIBLE TO USE THEM WITHOUT CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366885 CT CONTRAST INJECTOR SYRINGES INJECTOR, CONTRAST MEDIUM, AUTOMATIC IZQ BRACCO INJENEERING S.A./ BRACCO INJENEERING

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Unknown Other