inforMED
MalfunctionFOS

UMBILI-CATH A DUAL-LUMEN SILICONE UMBILICAL CATHETER, 5 FRENCH

Received May 18, 2023 · Event occurred Apr 15, 2023

Report 16952792 · MDR key 16952792

Device

Generic name

Catheter, Umbilical Artery

Lot number

1223035

Product problems

  • Use of Device Problem
  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

REPLACEMENT PRODUCT FOR DUAL LUMEN 5 FR UMBILICAL CATHETER - THE LUER LOCK ENDS OF THE LUMENS PULL OFF WITH TUBING CHANGE - THEY AREN'T PERMANENTLY ATTACHED AND ARE NOT LUER LOCK ATTACHED ON CENTRAL LINE. VERY DANGEROUS IF CAP COMES OFF THERE COULD BE LEAKING, BLEEDING, CENTRAL LINE INFECTION, AIR EMBOLISM.