MalfunctionFPB

HEMO-NATE FILTER DISPOSABLE 18 MICRON BLOOD FILTER

Received Dec 4, 2024 · Event occurred Oct 25, 2024

Report 20842203 · MDR key 20842203

Device

Generic name

Filter, Infusion Line

Manufacturer

Utah Medical Products, Inc.

Model number

FILTER

Catalog number

4020009

Lot number

1231193

Patient

6 DA · Male

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

Narrative

Description of Event or Problem

AN RN (REGISTERED NURSE) WAS ASSEMBLING BLOOD FILTER TO DRAW UP BLOOD, THE FILTER BROKE AT THE SITE OF THE LUER LOCK AND FILTER CONNECTION. PACKAGING WAS NOT SAVED FOR PRODUCT. THIS HAPPENED ON TWO DIFFERENT OCCURRENCES, ONE SET OF PACKAGING SAVED. NEW FILTER WAS USED WITHOUT ISSUE. NO HARM TO PATIENT.