inforMED
MalfunctionOGE

PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY

Received Apr 16, 2025 · Event occurred Apr 8, 2025

Report MW5169140 · MDR key 21850871

Device

Generic name

Epidural Anesthesia Kit

Lot number

0061964610

Product problems

  • Entrapment of Device
  • Mechanical Problem
  • Material Separation

Patient

33 YR · Female

  • Fetal Distress
  • Fetal Distress

Narrative

Description of Event or Problem

DURING PLACEMENT OF LUMBAR EPIDURAL CATHETER (DURING LABOR AND DELIVERY), THE CATHETER WOULD NOT THREAD. UPON REMOVAL OF CATHETER AND TUOHY NEEDLE TOGETHER CATHETER CAME OUT WITH APPROXIMATELY 1CM OF TIP SHEARED OFF. UNABLE TO FIND CATHETER TIP IN AREA SURROUNDING PATIENT. ANESTHESIA ALSO FOLLOWING UP WITH NEUROSURGERY TO DETERMINE RECOMMENDED FOLLOW UP PLAN. PATIENT IS G1P0 AT 40.2 WEEKS. PREGNANCY HAS BEEN COMPLICATED BY MATERNAL CELIAC, IRON DEFICIENCY, AND HSV WITH HSV PROPHYLAXIS STARTED AT 36 WEEKS. GBS NEGATIVE. SROM AT HOME; LABORED FOR SEVERAL HOURS BEFORE EPIDURAL WAS INSERTED. PATIENT ULTIMATELY HAD CESAREAN DELIVERY DUE TO FETAL DECELERATIONS.