MalfunctionOGE

PERIFIX

Received Apr 7, 2025 · Event occurred Mar 28, 2025

Report MW5168662 · MDR key 21786434

Device

Generic name

Epidural Anesthesia Kit

Manufacturer

B. Braun Medical Inc.

Catalog number

REF 332079

Lot number

0061969209

Product problems

Leak/Splash
Use of Device Problem

Patient

NA · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PREGNANT FEMALE HAD EPIDURAL CATHETER PLACED BY CRNA (CERTIFIED REGISTERED NURSE ANESTHETIST) WITHOUT ANY DIFFICULTY. A WHILE LATER THE PATIENT NOTIFIED THE NURSE THAT HER SHOULDER WAS WET. ALLIGATOR CLAMP ON EPIDURAL LINE DISCOVERED UNCLAMPED. CLAMP CLOSED AND THEN TAPED SHUT.