inforMED
MalfunctionFOS

UMBILI-CATH

Received Mar 31, 2026 · Event occurred Mar 6, 2026

Report 1718873-2026-00001 · MDR key 24744634

Device

Generic name

Umbilical Catheter

Catalog number

4173505

Lot number

EITHER 1251067 OR 1251522

Product problems

  • Material Split, Cut or Torn

Patient

NA · Unknown

  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

UTMD IS REPORTING THIS EVENT BECAUSE THE USER REPORTED THAT AN INTERVENTIONAL RADIOLOGY / INTERVENTIONAL CARDIOLOGY WAS PERFORMED TO REMOVE THE SEVERED CATHETER FROM THE PATIENT. HOSPITAL STAFF CONFIRMED THAT NO BLOOD LOSS OCCURRED RELATED TO THE BREAKING OF THE UVC, THE CATHETER WAS RETRIEVED WITH MINIMAL BLOOD LOSS. PRODUCT HAS NOT BEEN RETURNED TO UTMD FOR EVALUATION.

Description of Event or Problem

THE CATHETER WAS BEING REMOVED AFTER IT WAS NO LONGER NEEDED. THE CATHETER BROKE DURING THE SECOND ATTEMPT AT REMOVAL. THE INTERNALIZED PORTION OF THE CATHETER WAS RETRIEVED BY INTERVENTIONAL RADIOLOGY/INTERVENTIONAL CARDIOLOGY. NO BLOOD LOSS OCCURRED RELATED TO THE BREAKING OF THE UVC.