inforMED
MalfunctionGCD

PORTEX® EPIFUSE® EPIDURAL CATHETER CONNECTOR

Received May 11, 2018 · Event occurred Aug 11, 2015

Report 3012307300-2018-10048 · MDR key 7508288

Device

Generic name

Connector, Catheter

Catalog number

EPX1095/118JP

Lot number

99999

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

NO PRODUCT WAS RETURNED SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER USED THE EPIFUSE CONNECTOR WITH THE COMBINATION WITH THE HAKKO'S FILTER. DURING USE THE LEAKAGE OCCURRED FROM THE CONNECTION OF THE BOTH COMPONENTS.