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	10/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While scanning a cta (computed tomography angiography) coronary study, the contrast was hooked up to the patient's iv.As soon as the injection started, we heard a loud noise which turned out to be the injector (contrast side) exploding and causing a piece of its plastic base to come apart and fall onto the floor.The patient was unharmed, but it did delay the scan time and could have posed a physical risk to patient and staff.

• 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: 20577068
• Report Number: 20577068
• Device Sequence Number: 8096263
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880
• 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): 10/14/2024
• Report Date (Section F): 10/14/2024

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: 257836
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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 Age: 2 MO
• Patient Sex: Female
• Patient Weight: 52 KG
• Date Report Sent to FDA: 10/14/2024