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

Model Number	017354
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6)-year-old female for procedure: ct of the chest.Syringes inspected during set up with no visible defects.Injector initiated.Injector monitor alarmed slightly for pressure limit.The rate of injection was 2.5 ml/sec.Once the alarm went off, the injector slowed injection to 1.5 ml/sec.Upon inspection, the syringe on the saline side was broken.No known harm to patient.Exam did not require repeating.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: 20266668
• Report Number: 20266668
• Device Sequence Number: 12617107
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880(17)270625(10)257836
• 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): 08/28/2024
• Report Date (Section F): 08/28/2024

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: 257836
• 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: 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: Female
• Date Report Sent to FDA: 08/28/2024