MalfunctionDXT
MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL
Received Dec 8, 2025 · Event occurred Nov 3, 2025
Report 23739122 · MDR key 23739122
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
P/l BiomedicalModel number
400109Catalog number
400109
Lot number
208645
Product problems
- Material Separation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A PATIENT WAS IN PROCESS OF BEING GIVEN IV CONTRAST FOR A CT SCAN, AND DURING INJECTION BY AUTO-INJECTOR ON CT SCANNER, THE SYRINGE SEPARATED FROM BASE; SYRINGE WAS REPLACED AND SCAN WAS PERFORMED WITHOUT FURTHER INCIDENT.