inforMED
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

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.