inforMED
MalfunctionFPB

GARDIAN 25 MM SYRINGE FILTER

Received May 23, 2024 · Event occurred Jan 26, 2024

Report 19380550 · MDR key 19380550

Device

Generic name

Filter, Infusion Line

Model number

6094184

Catalog number

6094184

Lot number

13507679

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WHEN MAKING AN INTRATHECAL CHEMOTHERAPY AND FILTERING THE INGREDIENTS THE DISC FILTER MEMBRANE COMPLETELY DISINTEGRATED, BUT DID NOT REACH THE PATIENT.