MalfunctionFOS
UMBILICAL CATHETER
Received Aug 11, 2022 · Event occurred Aug 7, 2022
Report MW5111447 · MDR key 15216952
Device
Product problems
- Fluid/Blood Leak
Patient
2 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DOUBLE LUMEN UVC CATHETER 3.5FR MADE BY UTAH MEDICAL PRODUCTS WITH A LEAK AT THE JUNCTURE OF THE DUAL LUMENS INTO THE MAIN CATHETER. FDA SAFETY REPORT ID# (B)(4).