inforMED
MalfunctionDXT

MEDICAL IMAGING SOLUTIONS INTL.

Received Oct 27, 2025 · Event occurred Apr 21, 2025

Report 23389903 · MDR key 23389903

Device

Generic name

Injector And Syringe, Angiographic

Model number

400109

Lot number

2503333, 2503336, 2503339

Product problems

  • Contamination
  • Product Quality Problem

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WE WERE INFORMED BY THE MANAGER OF RADIOLOGY AT [REDACTED] THAT CT INJECTOR SYRINGES HAD CONDENSATION. HE LISTED AFFECTED LOT #2503333, 2503336, 2503339. I OPENED ONE SET OF SYRINGE PACKAGING (LOT # 2503333) AND THERE IS EVIDENCE OF CONDENSATION. I PULLED THE TWO CASES IN OUR STOCK, AND THE 6 INDIVIDUAL UNOPENED SETS AND SENT THEM TO CENTRAL SUPPLY TO ADD TO THE OTHER CASES TO BE SENT BACK. [REDACTED] FROM CENTRAL SUPPLY SAID SHE WOULD REACH OUT TO THE SUPPLIER.