inforMED
MalfunctionOGE

CONTINUOUS EPIDURAL ANESTHESIA TRAY - CLAMP CATHETER CONNECT

Received Sep 4, 2025 · Event occurred Aug 16, 2025

Report 22962387 · MDR key 22962387

Device

Generic name

Epidural Anesthesia Kit

Lot number

0062015110

Product problems

  • Fluid/Blood Leak

Patient

27 YR · Female

  • Emotional Changes
  • Emotional Changes

Narrative

Description of Event or Problem

PATIENT BEGAN TO GET INCREASINGLY UNCOMFORTABLE AFTER HER EPIDURAL HAD BEEN WORKING. IT WAS NOTED THAT HER GOWN WAS WET AND UPON FURTHER ASSESSMENT, I COULD SEE THAT THE EPIDURAL MEDICATION WAS LEAKING FROM THE ROUND, YELLOW FILTER THAT CONNECTS TO THE CADD [CONTINUOUS AMBULATORY DRUG DELIVERY] PUMP TUBING. ANESTHESIOLOGIST WAS NOTIFIED AND WAS ABLE TO REPLACE THE DEFECTIVE YELLOW FILTER PIECE. EPIDURAL BEGAN WORKING AGAIN FOR PATIENT AFTER FILTER REPLACEMENT.