inforMED
MalfunctionOGE

PERIFLEX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY

Received May 7, 2025 · Event occurred Sep 29, 2024

Report MW5170060 · MDR key 21978489

Device

Generic name

Epidural Anesthesia Kit

Model number

CE17TKFC

Catalog number

332079

Product problems

  • Connection Problem
  • Device Dislodged or Dislocated

Patient

36 YR · Female

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

Narrative

Description of Event or Problem

B. BRAUN PERIFLEX CONTINUOUS EPIDURAL CATHETER BECAME DISLODGED FROM THE FEMALE LUER LOCK CONNECTOR (ALLIGATOR CLAMP) TOWARDS THE END OF PATIENT'S LABOR -NEAR TO WHEN PATIENT BECAME COMPLETE. THE DISCONNECTION WAS NOT IMMEDIATELY RECOGNIZED BY NURSING STAFF OR PATIENT AND PATIENT DID NOT HAVE ADEQUATE PAIN CONTROL DURING DELIVERY. THIS TIMING MADE REPLACEMENT NOT FEASIBLE. THE LUER LOCK CONNECTOR HAS COME APART ON NUMEROUS PATIENTS LEADING TO POOR PAIN CONTROL AND INCREASING NEED TO REPLACE THE CATHETER. THIS INCREASES RISK OF COMPLICATION INCLUDING INFECTION, POST DURAL PUNCTURE, BLEEDING, ETC. WE HAVE COMMUNICATED WITH B. BRAUN TO NO AVAIL. THEIR RESPONSE IS TO TAPE THE CONNECTION TOGETHER WHICH IS NOT A SOLUTION TO A HARDWARE PROBLEM.