BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE SINGLE 200CC INJECTOR SY

    MDR report key: 20863327 · Received December 6, 2024

    Report

    Report Number
    MW5163243
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 3, 2024
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/3/2025 FOR REPORT NUMBER MW5163243 TO UPDATE THE MANUFACTURER NAME TO BRACCO INJENEERING S.A.

    Description of Event or Problem · 0

    WITH INVESTIGATION, SYSTEM WIDE TRENDING, AND INTERVIEWS IT HAS BEEN IDENTIFIED THAT SINCE (B)(6) 2024 WE HAVE HAD A MINIMUM OF 31 SEPARATE EVENTS WHERE WEAK INJECTOR SYRINGES ARE BREAKING AT TIMES COMING OF OFF OF THE INJECTOR OR BROKE AND AT TIMES SENT PROJECTILES OUT OF THE PUMP PUT BOTH PATIENTS AND STAFF AS RISK OF INJURY AND DELAYING STUDIES. THERE HAVE BEEN MEETINGS WITH THE BRACCO REP AND WE WERE INFORMED THAT HAS NOT BEEN A VOLUNTARY RECALL BUT THEY HAVE IDENTIFIED A PRODUCT ISSUE WITH MANUFACTURING AND THEY PLAN TO REPLACE OUR PRODUCTS NOW THEY HAVE ALTERED THE MANUFACTURING PROCESS. (B)(4); 017345 SYRINGE SINGLE 200CC INJECTOR SYSTEM QUADPAK EMPOWERCT STA INJECTOR SYSTEM FASTLOAD. REF REPORT: MW5163244.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/9/2024 FOR REPORT MW5163243 TO UPDATE THE MANUFACTURER TO BRACCO DIAGNOSTICS INC./ E-Z-EM, INC.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/19/2024 FOR A REPORT NUMBER MW5163243 TO UPDATE THE MANUFACTURER NAME TO ACIST MEDICAL SYSTEMS INC/ BRACCO DIAGNOSTIC INC. WITH INVESTIGATION, SYSTEM WIDE TRENDING, AND INTERVIEWS IT HAS BEEN IDENTIFIED THAT SINCE 6/2024 WE HAVE HAD A MINIMUM OF 31 SEPARATE EVENTS WHERE WEAK INJECTOR SYRINGES ARE BREAKING AT TIMES COMING OF OFF OF THE INJECTOR OR BROKE AND AT TIMES SENT PROJECTILES OUT OF THE PUMP PUT BOTH PATIENTS AND STAFF AS RISK OF INJURY AND DELAYING STUDIES. THERE HAVE BEEN MEETINGS WITH THE BRACCO REP AND WE WERE INFORMED THAT HAS NOT BEEN A VOLUNTARY RECALL BUT THEY HAVE IDENTIFIED A PRODUCT ISSUE WITH MANUFACTURING AND THEY PLAN TO REPLACE OUR PRODUCTS NOW THEY HAVE ALTERED THE MANUFACTURING PROCESS. WD#: (B)(4)- BRACCO DIAGNOSTICS INC 017345 SYRINGE SINGLE 200CC INJECTOR SYSTEM QUADPAK EMPOWERCT STA INJECTOR SYSTEM FASTLOAD. REFERENCE REPORT: MW5163244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114390 SYRINGE SINGLE 200CC INJECTOR SY INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO INJENEERING S.A. 017345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other