MalfunctionFOS
UMBILI-CATH A DUAL-LUMEN SILICONE UMBILICAL CATHETER, 5 FRENCH
Received Dec 19, 2024 · Event occurred Sep 28, 2024
Report 20975959 · MDR key 20975959
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Utah Medical Products, Inc.Model number
DUAL-LUMEN SILICONECatalog number
4275005
Lot number
1232854
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE 5 FRENCH DOUBLE LUMEN UMBILICAL CATHETER HAD A HOLE IN IT. THE LINE WAS INSERTED AND VERIFIED VIA X-RAY WHEN PROVIDER NOTICED IT WAS LEAKING WHEN FLUSHED. UPON FURTHER INVESTIGATION, THE HOLE WAS NOTED IN ONE OF THE LUMENS. THE LINE WAS THEN REMOVED AND A NEW ONE WAS INSERTED.