MalfunctionFOS
ARGYLE
Received Jun 17, 2026 · Event occurred Jun 10, 2026
Report 1423537-2026-00197 · MDR key 25531910
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health 200, LlcModel number
8888160531Catalog number
8888160531
Lot number
2521700021
Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE DUAL LUMEN UMBILICAL CATHETER WAS FOUND TO HAVE A SMALL HOLE/CRACK IN THE CATHETER. THERE WAS NO HARM REPORTED. IT WAS CAUGHT FAIRLY QUICKLY HOWEVER, SINCE THAT WAS CONSIDERED A CENTRAL LINE, THERE IS ALWAYS A RISK FOR INFECTION. THE CATHETER WAS REMOVED AND PIV WAS PLACED.