MalfunctionFPB

ICU MEDICAL 0.2 MICRON FILTER

Received Jun 17, 2026 · Event occurred Jun 9, 2026

Report MW5189603 · MDR key 25536685

Device

Generic name

Filter, Infusion Line

Manufacturer

Icu Medical, Inc

Lot number

14847044

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PRIOR TO USE ON PATIENT, STAFF INSPECTED ICU MEDICAL IV TUBING DUE TO ONGOING CONCERNS WITH CONTAMINATIONS. BLACK SPECK FOUND IN TUBING SECTION OF 0.2 MICRON FILTER.