MalfunctionFOS
NA
Received Oct 12, 2022 · Event occurred Sep 14, 2022
Report 15592556 · MDR key 15592556
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Footprint Medical, Inc.Model number
P2UVC3.5Lot number
220099
Product problems
- Defective Device
Patient
1 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SUBSTITUTE ITEM WAS USED TO PLACE UMBILICAL LINES ON PATIENT. AFTER LINE WAS PLACED, LINE WAS NOT WORKING (DRAWING BACK, NO FLUIDS WERE GETTING TO PATIENT) AND PROVIDER DETERMINED THE LINE NEEDED TO BE PULLED OUT OF PATIENT AND REPLACED WITH DIFFERENT CATHETER.