MAUDE Adverse Event Report: BRACCO INJENEERING S.A FASTLOAD MR SYRINGE PACK; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number	017356
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Power injector syringe leaked out of bottom of syringe into injector after unhooking from patient.

• Brand Name: FASTLOAD MR SYRINGE PACK
• Common Device Name: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING S.A; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 20266320
• Report Number: 20266320
• Device Sequence Number: 16979009
• Product Code: IZQ
• UDI-Device Identifier: 17630039300866
• UDI-Public: (01)17630039300866
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/16/2024
• Report Date (Section F): 09/16/2024

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: 017356
• Device Catalogue Number: 017356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• 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: 09/16/2024