inforMED
MalfunctionOGE

PERIFIX FX CONTINUOUS EPIDURAL

Received Jul 1, 2025 · Event occurred Jun 27, 2025

Report MW5172167 · MDR key 22374920

Device

Generic name

Epidural Anesthesia Kit

Model number

CE17TKFC

Catalog number

332079

Lot number

0062004931

Product problems

  • Fluid/Blood Leak
  • Material Puncture/Hole

Patient

24 YR · Female

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

Narrative

Description of Event or Problem

PERIFIX EPIDURAL CATHETER WAS PLACED EASILY, DURING TEST DOSE, FLUID SPRAYED OUT OF A HOLE IN THE SIDE OF THE CATHETER DISTAL TO INSERTION SITE. THE CATHETER WAS REMOVED. PATIENT WAS INFORMED THAT THE EPIDURAL WOULD NEED TO BE REPEATED. A SECOND KIT WAS OPENED, AND A NEW NEEDLE WAS PLACED, CATHETER INTRODUCED, BOLUS DOSE GIVEN WITH NO ISSUE. CONTINUOUS INFUSION SET UP AND INFUSING WITH NO ISSUES.