MalfunctionDXT

MEDICAL IMAGING SOLUTIONS INTL. MISI

Received May 28, 2025 · Event occurred Apr 17, 2025

Report 22095222 · MDR key 22095222

Device

Generic name

Injector And Syringe, Angiographic

Manufacturer

Darco International Corporation

Model number

400109

Lot number

2503333

Product problems

Contamination

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

MISI CT POWER INJECTOR SYRINGES APPEAR TO HAVE CONDENSATION/LIQUID OF SOME KIND INSIDE OF THEM UPON OPENING THE PACKAGING, WHICH IS ABNORMAL AND COULD INDICATE NON-STERILITY OR SOME KIND OF CONTAMINANT IN THE SYRINGES.