inforMED
MalfunctionFOS

UMBILI-CATH

Received May 14, 2025 · Event occurred Apr 30, 2025

Report 1718873-2025-00001 · MDR key 22020539

Device

Generic name

Umbilical Vessel Catheter

Catalog number

4173505

Lot number

1241222

Product problems

  • Human-Device Interface Problem
  • Human-Device Interface Problem

Patient

NA · Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

CUSTOMER REPORTED THE HARD PLASTIC HUB WAS REMOVED INADVERTENTLY FROM THE SILICONE HUB.

Additional Manufacturer Narrative

UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF ESTIMATED THAT THE PATIENT LOST APPROXIMATELY 3ML OF BLOOD FROM A 500G INFANT. THE PATIENT DID NOT NEED A BLOOD TRANSFUSION. NO PRODUCT WAS AVAILABLE FOR RETURN FOR EVALUATION. THE SILICONE CATHETER HAS A RIDGED BARBED LUER HUB WHICH IS FRICTION FIT INTO THE SILICONE CATHETER. THE LUER HUB CAN BE PULLED OUT OF THE SILICONE SOCKET IF EXCESSIVE FORCE AND MANIPULATION ARE APPLIED. AFTER A WEEK OF USE, THE NURSE REMOVED THE RIDGED LUER HUB FROM THE SILICONE CATHETER (INSTEAD OF UNSCREWING THE LUER CONNECTION) AND FORCE AN IV TUBING LUER CONNECTOR INTO THE SILICONE CATHETER SOCKET. THIS UNSTABLE CONNECTION LATER CAME LOOSE CAUSING THE BLOOD LOSE. THIS IS AN ISOLATED OCCURRENCE.