MalfunctionDXT

FASTLOAD CTA DUAL SYRINGE PACK

Received Mar 25, 2025 · Event occurred Mar 20, 2025

Report 21686772 · MDR key 21686772

Device

Generic name

Injector And Syringe, Angiographic

Manufacturer

Bracco Injeneering S.a

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

THE INJECTOR DOORS THAT HOLD THE SYRINGE ON THE INJECTOR MALFUNCTIONED ON THE CONTRAST SIDE. THERE IS A SILVER BUTTON THAT LOCKS THE DOOR, THIS SILVER BUTTON WAS STICKING OUT AND WE WERE UNABLE TO CLOSE THE DOOR. AFTER REBOOTING THE INJECTOR AND CHANGING THE SYRINGES, THE INJECTOR DOOR DID SHUT AND FUNCTIONED AS NORMAL. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SENDING SERVICE REP/TEAM TO EVALUATE.