inforMED
MalfunctionFOS

UMBILI-CATH A SINGLE LUMEN SILICONE UMBILICIAL CATHETER 3.5 F

Received Jun 9, 2025 · Event occurred Feb 18, 2025

Report 22166060 · MDR key 22166060

Device

Generic name

Catheter, Umbilical Artery

Product problems

  • Contamination /Decontamination Problem
  • Activation, Positioning or Separation Problem
  • Material Integrity Problem

Patient

4 DA · Female

  • Bacterial Infection
  • Bacterial Infection

Narrative

Description of Event or Problem

ADAPTER ON END OF UAC [UMBILICAL ARTERY CATHETER] HAD BEEN BECOME DISLODGED. NO LUER LOCK SYSTEM IN PLACE TO AVOID AIR EMBOLISM OR BLOOD LOSS. ESTIMATED INFANT BLOOD LOSS OF 3ML (500-GRAM INFANT). +CLABSI [CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION].