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	08/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with recent blurred vision and paresthesia.Procedure: ct head.Scan cow (circle of willis)/carotid and timing bolus was faint and hard to determine on screen.Observation in scan room identified minimal amount of contrast got to patient, the majority of the contrast was on the floor.Leak of contrast from tubing site or connection unidentified.Patient received a reload of contrast and an additional 20cc and administered another timing bolus.No known harm to patient but delay in patient care.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: 20075095
• Report Number: 20075095
• Device Sequence Number: 20476352
• Product Code: DXT
• UDI-Device Identifier: 17630039300880
• UDI-Public: (01)17630039300880(17)270625(10)257836(11)240625
• 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): 08/20/2024
• Report Date (Section F): 08/20/2024

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: Other
• 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: 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: 69 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Date Report Sent to FDA: 08/20/2024