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	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A bracco ct fastload syringe was noticed to have broken pieces in package upon opening.Tech noticed white pieces from syringe in packaging and did not use syringe.All parts and packaging saved.Lot#244589.Expiration 2026-10-10.

• 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: 18737796
• Report Number: 18737796
• Device Sequence Number: 12570003
• 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
• Device Explanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024
• Report Date (Section F): 01/23/2024

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: 244589
• 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: 02/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• 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: Unknown
• Date Report Sent to FDA: 01/23/2024