MalfunctionOGE

DESIGN OPTIONS®

Received Jul 22, 2024 · Event occurred Apr 24, 2024

Report 19792659 · MDR key 19792659

Device

Generic name

Epidural Anesthesia Kit

Manufacturer

B. Braun Medical Inc.

Model number

552116

Catalog number

552116

Lot number

0061896193

Patient

26 YR · Female

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

Narrative

Description of Event or Problem

AN EPIDURAL WAS PLACED AT [DATE REDACTED]. THE NEXT DAY THE EPIDURAL CATHETER WAS REMOVED AND REPLACED DUE TO LEAKING. THE CATHETER HAD COME OUT OF THE YELLOW "ALLIGATOR CLIP" CLIPS ONTO THE END OF THE CATHETER. MD REPLACED THE EPIDURAL. HE SAID THAT THE CATHETER SHOULDN'T HAVE BEEN ABLE TO COME OUT EASILY FROM THAT CLIP. MANUFACTURER RESPONSE FOR EPIDURAL ANESTHESIA KIT, (B)(6) (PER SITE REPORTER). EMAILED - NO RESPONSE YET.