MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FASTLOAD CTA DUAL SYRINGE PACK; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	017354
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Injector was filled per protocol without any issues.Patient was hooked to the injector for the scan.When the tech started the injection, they heard a "pop", the tech immediately stopped the injector (it did not stop on its own).Upon investigating the syringe was busted on the contrast side.The tech unhooked from the tubing and removed all pieces.Information was sent to bracco & risk management.The patient was not harmed by this error.Patient's scan was then finished without any other issues.Manufacturer response for injector and syringe, angiographic, fastload cta dual syringe pack (per site reporter).Service staff coming to inspect.

• Brand Name: FASTLOAD CTA DUAL SYRINGE PACK
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BRACCO INJENEERING S.A.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 21686649
• Report Number: 21686649
• Device Sequence Number: 15780050
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/24/2025
• Report Date (Section F): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 017354
• Device Catalogue Number: 017354
• Device Lot Number: 268541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 03/24/2025