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	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fastload ct syringe exploded while performing injection.No patient injury or harm.After evaluating the lot number, it was determined that this lot # of syringe was recalled in december.We went through the department and 48 case plus 300 in the department were recalled.Bracco had sent facility products that were recalled already.Boxes with lot #261714 was received by our facility january 2025.The syringe used on this patient was pulled from this box filled with the recalled lot number.
Event or Problem Description
Fastload ct syringe exploded while performing injection.No patient injury or harm.After evaluating the lot number, it was determined that this lot # of syringe was recalled [redacted].We went through the department and 48 case plus 300 in the department were recalled.Bracco had sent facility products that were recalled already.Boxes with lot #261714 was received by our facility [redacted].The syringe used on this patient was pulled from this box filled with the recalled lot number.

• 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: 21277205
• Report Number: 21277205
• Device Sequence Number: 19754999
• Product Code: DXT
• UDI-Device Identifier: 37630039300877
• UDI-Public: (01)37630039300877(17)270828(11)240828(10)261714
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025
• Report Date (Section F): 01/24/2025

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
• Device Model Number: 017355
• Device Catalogue Number: 017355
• Device Lot Number: 261714
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 10/24/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/24/2025