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	Insufficient Information (4580)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A fastlload cta dual syringe pack, from lot 241679, was placed on the injector head and the contrast and saline loading process was initiated.The ct tech walked away to place a sheet on the exam table and to distance myself from the head unit.No audible noise was made , but when the ct tech stepped back to the injector he noticed the black and white plunger on the contrast side was stuck at the top of the syringe and some white plastic was missing.

• 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: 18265654
• Report Number: 18265654
• Device Sequence Number: 14442099
• 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): 10/11/2023
• Report Date (Section F): 10/11/2023

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: 241679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/11/2023