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	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was being injected through a powerport and the contrast syringe broke and popped off the power injector.Plastic pieces dispersed but a curtain barrier was used and the patient was not harmed.Injector syringes were replaced and test successfully completed.

• 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: 18266142
• Report Number: 18266142
• Device Sequence Number: 18107668
• 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): 10/02/2023
• Report Date (Section F): 10/02/2023

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: 242411
• 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: 12/05/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2023
• 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: 69 KG
• Patient Race: White
• Date Report Sent to FDA: 10/02/2023