inforMED
MalfunctionOGE

PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA TRAY

Received Jul 23, 2024 · Event occurred Jul 5, 2024

Report MW5157503 · MDR key 19819351

Device

Generic name

Epidural Anesthesia Kit

Model number

CE17TKFC

Catalog number

332079

Lot number

0061929960

Patient

27 YR · Female

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

Narrative

Description of Event or Problem

A 27 YO FEMALE WITH 39W GESTATION ADMITTED FOR INDUCTION OF LABOR. AFTER PATIENT'S EPIDURAL PLACED BY CRNA(CERTIFIED REGISTERED NURSE ANESTHETIST), CRNA WENT TO PICK UP GLASS SYRINGE OUT OF EPIDURAL KIT AND GLASS SYRINGE EXPLODED WITH CRNA TOUCH. GLASS SHARDS ONTO FLOOR AND BED. CRNA REPLACED KIT WITH A NEW ONE TO FINISH WITH PROCEDURE AND REPLACED FILTER ON EPIDURAL LINE. GLASS SHARDS DID NOT REACH/ HARM PATIENT OR STAFF. NO HARM.