MalfunctionDXT

SINGLE SYRINGE KITS - 1-200ML SYRINGE, 1-60" COILED TUBING, 1 FILL STRAW

Received Dec 18, 2025 · Event occurred Dec 11, 2025

Report MW5180781 · MDR key 23837829

Device

Generic name

Injector And Syringe, Angiographic

Manufacturer

Chs / Shenzhen Lnkmed Medical Technology Co., Ltd.

Model number

100101

Lot number

2503182

Product problems

Product Quality Problem
Moisture or Humidity Problem
Product Quality Problem
Moisture or Humidity Problem

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

MISI CT INJECTOR SYRINGES PURCHASED THROUGH CHS CONTAIN CONDENSATION INSIDE THE SYRINGES. CHS CLAIMED THE CONDENSATION IS FROM MEDIAL GRADE SILICONE OIL. THIS IS THEIR EXPLANATION "THE PHENOMENON OF SILICONE OIL CONDENSATION WILL NOT AFFECT THE NORMAL USE OF THE PRODUCT. THE SILICONE OIL USED BY OUR COMPANY IS MEDICAL GRADE SILICONE OIL, WHICH FULLY COMPLIES WITH RELEVANT NATIONAL STANDARDS, IS SAFE, NON-TOXIC, AND HARMLESS TO THE HUMAN BODY." THEY OFFERED TO REPLACE THE THREE IDENTIFIED DEFECTIVE LOTS 2503182, 2504192 AND 2503183. PT CODE: 4580. DEVICE CODES: 1506, 2986. REF REPORTS: MW5180780, MW5180782.