inforMED
MalfunctionDXT

FASTLOAD¿ CTA DUAL SYRINGE PACK WITH SPIKES

Received Nov 8, 2023 · Event occurred Sep 17, 2023

Report 18092056 · MDR key 18092056

Device

Generic name

Injector And Syringe, Angiographic

Model number

017355

Catalog number

017355

Lot number

241077

Patient

Female

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

Narrative

Description of Event or Problem

PATIENT WAS HAVING A CHEST CT DONE, WHILE INJECTING THE CONTRAST, THE SYRINGE BLEW OFF THE INJECTOR AND PARTS SHATTERED ON THE FLOOR. NO HARM TO PATIENT. IT WAS REPORTED THIS IS THE THIRD TIME THIS HAS HAPPENED WITH THESE SYRINGES.