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	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: ct- bracco injectors lot#: 251454, injectors obtained tubing cracks while injecting, contrast leaked all over.Tubes were not saved- no known harm to staff or patient.Procedure 2: ct- bracco injector top is broken off and unable to load contrast immediately after removing from packaging.Not used on patient.Tubes saved, packaging not.Manufacturer response for injector and syringe, angiographic, fastload cta dual syringe pack (per site reporter).Onsite at main campus reviewing possible issues.

• 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: 19380388
• Report Number: 19380388
• Device Sequence Number: 7538345
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880(17)270207(10)251454
• 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): 05/03/2024
• Report Date (Section F): 05/03/2024

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
• Operator of Device: Health Professional
• Device Model Number: 017354
• Device Catalogue Number: 017354
• Device Lot Number: 251454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• 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: 05/03/2024