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 Inflammation (1932)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Infiltration of iv contrast injection in a 20 gauge upper left arm of approximately 95 cc of contrast.Patient was returned to er for a new iv to complete the scan.

• 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: 15454555
• MDR Text Key: 300231543
• Report Number: 15454555
• 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: 25915 DA
• Patient Sex: Female