MalfunctionDXT
STERILE HIGH PRESSURE ANGIOGRAPHIC SYRINGES FOR SINGLE USE
Received Jan 21, 2026 · Event occurred Jan 14, 2026
Report MW5182586 · MDR key 24134157
Device
Patient
67 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT RECEIVING MRI CONTRAST VIA POWER INJECTION USING STANDARD IV INJECTION KIT. FOLLOWING CONTRAST INJECTION NOTED THAT THE CONTRAST WAS NOT ADMINISTERED AND THE PATIENTS BLOOD FLOWED BACKWARDS THROUGH THE CIRCUIT VIA A SMALL SPLIT AT THE DISTAL END OF THE TUBING PROVIDED WITH THE INJECTOR KIT JUST PROXIMAL TO THE HUB WHICH CONNECTS TO THE PATIENTS IV TUBING.