inforMED
MalfunctionFPB

MEDEX

Received Feb 20, 2022 · Event occurred Jan 19, 2022

Report 3012307300-2022-03712 · MDR key 13565903

Device

Generic name

Filter Infusion Line

Catalog number

MX493P1CZ

Product problems

  • Leak/Splash
  • Leak/Splash

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT WAS SUPPOSED TO BE USED AS A CONNECTOR IN EGMO THERAPY BUT DID NOT HOLD THE CONNECTION PROPERLY. THE ADAPTOR IS LEAKING BLOOD. NO PATIENT INJURY OCCURRED DUE TO THIS.