MalfunctionDXT
MEDICAL IMAGING SOLUTIONS INTL.
Received Oct 29, 2025 · Event occurred Jan 10, 2025
Report 23413330 · MDR key 23413330
Device
Generic name
Injector And Syringe, Angiographic
Manufacturer
Medical Imaging Solutions International CompanyModel number
400109Catalog number
400109
Lot number
2410174
Product problems
- Material Fragmentation
- Noise, Audible
Patient
90 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE INJECTING CONTRAST FOR CT PERFUSION STUDY ON A CODE STROKE PT, I HEARD A LOUD POP. THE INJECTOR CONTINUED TO ACT APPROPRIATELY FOR THE REMAINDER OF THE EXAM. WHEN COMPLETED, WE ENTERED THE CT ROOM TO RETURN PT TO HER BED AND NOTICED THE CONTRAST SYRINGE HAD BROKEN AT THE BASE, WITH A FEW PIECES STUCK UNDER THE PLUNGER.