MalfunctionFOS
5 FR URETHANE UMBILICAL CATHETER
Received Oct 30, 2014 · Event occurred Jul 13, 2014
Report 4226548 · MDR key 4226548
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Covidien LpModel number
N/ACatalog number
8888160341
Lot number
N/A
Product problems
- Crack
- Leak/Splash
Patient
1 DAY
- No Information
Narrative
Description of Event or Problem
A 5FR UAC LINE LEAKING. OCCURRED AFTER REMOVAL OF STOPCOCK CLOSEST TO LINE. RN FOLDED LINE OVER TO PREVENT BLOOD BACK UP, DISCONNECTED STOPCOCK, RECONNECTED IV TUBING. IMMEDIATELY STARTED TO LEAK BLOOD/IV FLUIDS THROUGH A CRACK/HOLE. HAD TO BE REMOVED AND BE REPLACED.