MAUDE Adverse Event Report: BRACCO INJENEERING SA 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	02/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Fastload cta power injector syringe was loaded into the injector.The ct tech began the injection and almost immediately, a very loud pop went off alarming the patient and tech.The injector syringe filled with contrast exploded off the injector and flew directly towards the patient.The base of the contrast syringe ring completely severed from the main portion of the syringe.
Event or Problem Description
Fastload cta power injector syringe was loaded into the injector.The ct tech began the injection and almost immediately, a very loud pop went off alarming the patient and tech.The injector syringe filled with contrast exploded off the injector and flew directly towards the patient.The base of the contrast syringe ring completely severed from the main portion of the syringe.

• Brand Name: FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 259 prospect plains road; monroe township NJ 08831
• MDR Report Key: 16544930
• Report Number: 16544930
• Device Sequence Number: 17644161
• 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,Followup
• Report Date (Section B): 02/27/2023
• Report Date (Section F): 03/02/2023

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: 229857
• 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: 03/15/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/19/2023
• 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: 85 KG
• Date Report Sent to FDA: 03/02/2023