MAUDE Adverse Event Report: BRACCO INJENEERING SA BRACCO CONTRAST INJECTOR; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infiltration into Tissue (1931)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

18 gauge left forearm iv access infiltrated approximately 50cc of contrast and 50 cc of saline during ct angio chest exam.The exam was completed.A new gauge iv access was established in the right and the patient was returned to the er.

• Brand Name: BRACCO CONTRAST INJECTOR
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BRACCO INJENEERING SA; 259 prospect plains road; monroe township NJ 08831
• MDR Report Key: 15454551
• MDR Text Key: 300231212
• Report Number: 15454551
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/07/2022,09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/07/2022
• Date Report to Manufacturer: 09/20/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28105 DA
• Patient Sex: Male