PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY
Received Apr 16, 2025 · Event occurred Apr 8, 2025
Report MW5169140 · MDR key 21850871
Device
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.