InjuryOGE
PERIFIX CONTINUOUS EPIDURAL ANESTHESIA SET
Received Jul 9, 2025 · Event occurred Jun 23, 2025
Report MW5172457 · MDR key 22460436
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical, Inc.Catalog number
332200
Lot number
0061972903
Product problems
- Material Separation
- Defective Device
Patient
60 YR · Male
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
PT (PATIENT) HAD AN EPIDURAL CATHETER PLACED INTRAOPERATIVELY FOR PAIN CONTROL FOLLOWING A MULTI-LEVEL POSTERIOR SPINAL FUSION. WHEN PA (PHYSICIAN ASSISTANT) WAS REVVING THE CATHETER IT SEPARATED AND A SECTION OF THE CATHETER REMAINED IN THE PTS BACK. THE PT RETURNED TO OR (OPERATING ROOM) LATER THAT AFTERNOON FOR AN EXPLORATION OF THE POST-OP LUMBAR WOUND AND REMOVAL OF RETAINED EPIDURAL CATHETER. THE SEGMENT WAS SUCCESSFULLY REMOVED. BOTH ANESTHESIOLOGISTS AND THE SURGEON FEEL THAT THE CATHETER WAS DEFECTIVE.