inforMED
InjuryFJD

E-Z CHEK BLOOD LEAK TEST STRIPS

Received Sep 2, 2025

Report MW5175409 · MDR key 22930166

Device

Generic name

Detector, Leak, Blood

Product problems

  • Output Problem
  • Pressure Problem

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

A REGISTERED NURSE (RN) CONTACTED (B)(6) CUSTOMER SERVICE VIA EMAIL TO REPORT THAT HANSON CONNECTOR AND LINE BOTH RESULTED NEGATIVE IN PRESENCE OF FRANK BLOOD LEAK WHILE USING THE E-Z CHEK BLOOD LEAK TEST STRIPS 25/BO. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).