inforMED
MalfunctionDXT

FASTLOAD CTA DUAL SYRINGE PACK

Received Apr 1, 2025 · Event occurred Mar 25, 2025

Report 21738199 · MDR key 21738199

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

WHITE TABS ON SYRINGE BROKE OFF WHILE LOADING CONTRAST. NO HARM TO PATIENT. DELAY IN CARE DUE TO HAVING TO SHUT DOWN INJECTOR AND REPLACE WITH SPARE. MANUFACTURER RESPONSE FOR INJECTOR AND SYRINGE, ANGIOGRAPHIC, FASTLOAD CTA DUAL SYRINGE PACK (PER SITE REPORTER). SERVICE PROFESSIONALS HAVE BEEN PRESENT IN THE FACILITY TO CHECK INJECTORS, THINK THIS MAY BE A SYRINGE ISSUE.