inforMED
MalfunctionFOS

NA

Received Apr 11, 2022 · Event occurred Feb 15, 2022

Report 14073330 · MDR key 14073330

Device

Generic name

Catheter, Umbilical Artery

Model number

S1UVC-3540

Catalog number

S1UVC-3540

Lot number

201467

Product problems

  • Break

Patient

Female

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

Narrative

Description of Event or Problem

REGISTERED NURSE (RN) WAS REMOVING A 3.5FR SINGLE LUMEN SILICONE UMBILICAL CATHETER, AND UPON GENTLY REMOVING CATHETER, THE CATHETER BROKE AT THE SUTURE LINE. PRESSURE WAS APPLIED BY RN, MD NOTIFIED IMMEDIATELY. MD ARRIVED AT BEDSIDE AND WAS ABLE TO GRAB THE REST OF THE CATHETER AT THE UMBILICUS AND ABLE TO REMOVE THE REST OF THE CATHETER. CATHETER LENGTH WAS VERIFIED BY RN TWICE. PRESSURE APPLIED BY MD AND RN UNTIL BLEEDING STOPPED.

Description of Event or Problem

REGISTERED NURSE (RN) WAS REMOVING A 3.5FR SINGLE LUMEN SILICONE UMBILICAL CATHETER, AND UPON GENTLY REMOVING CATHETER, THE CATHETER BROKE AT THE SUTURE LINE. PRESSURE WAS APPLIED BY RN, MD NOTIFIED IMMEDIATELY. MD ARRIVED AT BEDSIDE AND WAS ABLE TO GRAB THE REST OF THE CATHETER AT THE UMBILICUS AND ABLE TO REMOVE THE REST OF THE CATHETER. CATHETER LENGTH WAS VERIFIED BY RN TWICE. PRESSURE APPLIED BY MD AND RN UNTIL BLEEDING STOPPED.