MalfunctionFOS
UMBILI-CATH
Received Dec 11, 2025 · Event occurred Nov 13, 2025
Report 23777673 · MDR key 23777673
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Utah Medical Products, Inc.Model number
DUAL-LUMEN SILICONECatalog number
4275005
Lot number
1242381
Product problems
- Leak/Splash
- Material Puncture/Hole
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A DOUBLE LUMEN UMBILICAL CATHETER MADE OF SILICONE WAS INSERTED IN A PATIENT AND INFUSING MAINTENANCE FLUIDS. THE PATIENT WAS "WET" AROUND THE UMBILICUS. THE CATHETER WAS REMOVED AND A HOLE WAS FOUND IN THE SILICONE PORTION OF THE UMBILICAL LINE.