inforMED
MalfunctionDXT

MISI-MEDICAL IMAGING SOLUTIONS INTERNATIONAL

Received Jan 27, 2026 · Event occurred Jan 7, 2026

Report 24188568 · MDR key 24188568

Device

Generic name

Injector And Syringe, Angiographic

Model number

400109

Catalog number

400109

Lot number

208645

Patient

80 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A POWER INJECTOR SYRINGE, ON THE CONTRAST SIDE OF THE CT INJECTOR, BROKE AT THE BASE DURING AN INJECTION. THE INJECTOR WAS PUSHING CONTRAST AT A RATE OF 4 ML/S. THE SYRINGE BROKE AFTER 25 ML WAS INJECTED DURING THE BOLUS TRACKING MONITORING PHASE OF THE EXAM. SOME FAINT SIGNS OF CONTRAST ARE VISIBLE IN THE IMAGES. THE PARTS WERE COLLECTED. THE INJECTOR WAS LOADED WITH NEW SYRINGES AND THE EXAM WAS SUCCESSFULLY COMPLETED. NO HARM TO PATIENT OR STAFF. THE PARTS WERE SEQUESTERED AND GIVEN TO CT SUPERVISOR TO RETAIN FOR POSSIBLE VENDOR INVESTIGATION (WAS NOT GIVEN TO RISK DEPT DUE TO CONTRAST STILL IN SYRINGE).