inforMED
MalfunctionDXT

FASTLOAD CTA DUAL SYRINGE PACK

Received Mar 25, 2025 · Event occurred Mar 23, 2025

Report 21686773 · MDR key 21686773

Device

Generic name

Injector And Syringe, Angiographic

Model number

017354

Catalog number

017354

Lot number

270752

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WHEN I WAS ATTEMPTING TO LOAD CONTRAST INTO THE CONTRAST SYRINGE, I LITERALLY SAW THE WHITE PLASTIC TABS BREAK OFF INSIDE THE SYRINGE, AND AS THE PISTON WAS GOING DOWN AS THE CONTRAST WAS FILLING, IT GOT OFF LEVEL AND I HAD TO STOP WHAT I WAS DOING AND REMOVE THE BROKEN SYRINGE. I THEN HAD TO TURN THE MACHINE OFF, AND BACK ON, AND MANUALLY TWIST THE KNOB TO BRING THE PISTON BACK DOWN AND START ALL OVER. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE TEAM MEMBER COMING TO INSPECT THE INJECTOR, SERVICE TEAM TO LOOK AT THE SYRINGES.