inforMED
MalfunctionDXT

STERILE HIGH PRESSURE ANGIOGRAPHIC SYRINGES FOR SINGLE USE

Received Jan 21, 2026 · Event occurred Jan 14, 2026

Report MW5182586 · MDR key 24134157

Device

Generic name

Injector And Syringe, Angiographic

Lot number

250528

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.