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	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had a 20g peripheral iv flushed well prior to contrast.J loop was straight without resistance on hand flush.When tech attempted to inject contrast, two loud clicks were heard followed by psi on monitor shooting up to 300 psi.Injection was immediately halted before syringe had a chance to eject off the injector.

• Brand Name: FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 18091879
• Report Number: 18091879
• Device Sequence Number: 14983288
• 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): 09/20/2023
• Report Date (Section F): 09/20/2023

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
• Device Model Number: 017355
• Device Catalogue Number: 017355
• Device Lot Number: 241677
• 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: 11/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• 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: Female
• Patient Weight: 59 KG
• Patient Race: White
• Date Report Sent to FDA: 09/20/2023