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

Model Number	017355
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bracco ct power injector syringe failed during injection for coronary computed tomography angiography (ccta) exam.As per normal practice the syringe was visually checked prior to inserting into the power injector.No flaws were detected at this time and the ct tech had no issues attaching and filling syringes.During injection of isovue 370 for bolus tracker at 5.5cc/sec, a loud pop was heard.The ct tech, stopped the injection immediately and went in room to check on patient.There was no harm to patient.The tech then noticed the broken syringe hanging by the attached tubing.New syringe was opened and used to complete exam.Exam completed without further incident.

• Brand Name: FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BRACCO INJENEERING S.A.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 18570062
• Report Number: 18570062
• Device Sequence Number: 20590780
• Product Code: DXT
• UDI-Device Identifier: 17630039300873
• UDI-Public: (01)17630039300873
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2023
• Report Date (Section F): 12/05/2023

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: Other
• Device Model Number: 017355
• Device Catalogue Number: 017355
• Device Lot Number: 244895
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2024
• 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 Sex: Male
• Patient Weight: 114 KG
• Patient Race: White
• Date Report Sent to FDA: 12/05/2023