MalfunctionFOS
ARGYLE
Received Sep 1, 2021 · Event occurred Aug 1, 2021
Report 12404956 · MDR key 12404956
Device
Generic name
Catheter, Umbilical Artery
Model number
8888160333Catalog number
8888160333
Lot number
2007100042
Product problems
- Break
Patient
3 DA
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
DURING ITS REMOVAL, THE ARGYLE¿ UMBILICAL VESSEL CATHETER BROKE 1.5CM ABOVE THE INSERTION SITE. THE CATHETER LINE WAS HELD IN PLACE UNTIL PROVIDER ARRIVED. THE ENTIRE REMAINING LENGTH WAS REMOVED WITH A HEMOSTAT. BLOOD LOSS WAS MINIMAL.