MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FASTLOAD CTA DUAL SYRINGE PACK; INJECTOR AND SYRINGE, ANGIOGRAPHIC

Model Number	017354
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male.Procedure: ct angioplasty chest with contrast.Contrast leaked from injector/tubing connection during the injection.Tubing secure prior to injection but unable to see site of leakage.No known injury to patient.Manufacturer response for injector and syringe, angiographic, fastload cta dual syringe pack (per site reporter), will obtain.

• Brand Name: FASTLOAD CTA DUAL SYRINGE PACK
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC
• Manufacturer (Section D): BRACCO INJENEERING S.A.; 7905 fuller road; eden prairie MN 55344
• MDR Report Key: 20075091
• Report Number: 20075091
• Device Sequence Number: 6573799
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880(17)270604(11)240604(10)256819
• 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): 08/15/2024
• Report Date (Section F): 08/15/2024

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: 017354
• Device Catalogue Number: 017354
• Device Lot Number: 256819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/15/2024