MalfunctionFOS
UMBILI-CATH
Received Jan 18, 2023 · Event occurred Dec 28, 2022
Report 16194030 · MDR key 16194030
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Utah Medical Products, Inc.Model number
DUAL-LUMEN SILICONECatalog number
4275005
Lot number
1223034
Product problems
- Break
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
NEONATOLOGIST PLACED DOUBLE LUMEN UVC AND SUTURED IN PLACE. X-RAY CONFIRMATION OF PLACEMENT REVEALED CATHETER NEEDED TO BE WITHDRAWN. NEONATOLOGIST ATTEMPTED TO GENTLY PULL ON CATHETER TO WITHDRAW WHEN THE CATHETER BROKE. THE NEONATOLOGIST WAS ABLE TO GRASP THE REMAINING END OF THE CATHETER AND REMOVE FROM PATIENT BEFORE ENTERED CIRCULATION AND WITHOUT INCIDENT. WITHDRAWN CATHETER WAS INTACT