BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES

    MDR report key: 18265654 · Received December 5, 2023

    Report

    Report Number
    18265654
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    October 5, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BRACCO INJENEERING SA
    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 FASTLLOAD CTA DUAL SYRINGE PACK, FROM LOT 241679, WAS PLACED ON THE INJECTOR HEAD AND THE CONTRAST AND SALINE LOADING PROCESS WAS INITIATED. THE CT TECH WALKED AWAY TO PLACE A SHEET ON THE EXAM TABLE AND TO DISTANCE MYSELF FROM THE HEAD UNIT. NO AUDIBLE NOISE WAS MADE , BUT WHEN THE CT TECH STEPPED BACK TO THE INJECTOR HE NOTICED THE BLACK AND WHITE PLUNGER ON THE CONTRAST SIDE WAS STUCK AT THE TOP OF THE SYRINGE AND SOME WHITE PLASTIC WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235229 FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING SA 017355 241679 17630039300873

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown