MAUDE Adverse Event Report:; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

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

Patient Problem Extravasation (1842)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

Iv contrast extravasation 20cc isovue.

• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• MDR Report Key: 15454554
• MDR Text Key: 300231137
• Report Number: 15454554
• 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
• 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