MalfunctionFOS
UMBILI-CATH
Received Oct 19, 2018 · Event occurred Oct 10, 2018
Report 7983979 · MDR key 7983979
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Utah Medical Products, Inc.Model number
DUAL-LUMEN SILICONECatalog number
4273505
Lot number
1151487
Product problems
- Burst Container or Vessel
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
UMBILICAL CATHETER WAS USED FOR BLOOD DRAW ON NEONATE. NURSE WENT TO RETURN BLOOD AND SOMEWHERE NEAR THE CATHETER JUNCTION, THE LINE BUSTED/SQUIRTED OUT/BURST OPEN. MANUFACTURER RESPONSE FOR 3.5 FRENCH DUAL LUMEN SILICONE UVC CATHETER, UTAH MEDICAL (PER SITE REPORTER).