inforMED
MalfunctionFOS

5.0 FR X 32 CM DUAL LUMEN SILICONE UMBILICAL CATHETER

Received Jan 12, 2024 · Event occurred Oct 16, 2023

Report 18502349 · MDR key 18502349

Device

Generic name

Catheter, Umbilical Artery

Lot number

230005

Patient

Unknown

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

INITIAL EVENT SEVERITY RATING: EVENT REACHED PATIENT- CAUSED MINOR HARM OR REQUIRED MINIMAL INTERVENTION. EVENT DESCRIPTION: BEDSIDE RN (REGISTERED NURSE) WITH ORDER TO REMOVE UMBILICAL VEIN CATHETER. TAPE REMOVED TO BEGIN WITHDRAWAL PROCESS AND LINE SNAPPED IN RNS HAND. RN HELD ON TO RESIDUAL LINE INSIDE BABY AND MD (DOCTOR) CALLED TO BEDSIDE. LINE SUCCESSFULLY REMOVED. FULL CATHETER WAS REMOVED AS NOTED BY COUNT BACK, VIA LINE MEASUREMENT. BABY STABLE WITH NO BLEEDING. WILL CONTINUE TO MONITOR.