inforMED
MalfunctionOFE

CARDINAL HEALTH

Received Apr 18, 2025 · Event occurred Mar 18, 2025

Report 21864495 · MDR key 21864495

Device

Generic name

Central Venous Blood Pressure Kit

Model number

40-3938D

Catalog number

40-3938D

Lot number

307062

Product problems

  • Device Ingredient or Reagent Problem
  • Wrong Label

Patient

66 YR · Male

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

Narrative

Description of Event or Problem

REGISTERED NURSE (RN) OPENED A CENTRAL LINE REMOVAL KIT (REF#40-3938D) AND FOUND POVIDINE/IODINE FOR THE CLEANER INSTEAD OF CHLORHEXADINE, WHICH IS THE TYPICAL CLEANER. THE CONTENTS JUST SAYS APPLICATOR PREP. WE OPENED A SECOND KIT WITH THE SAME LOT # AND IT HAD THE STANDARD SUPPLIES. MANUFACTURER RESPONSE FOR CENTRAL VENOUS BLOOD PRESSURE KIT, CARDINAL HEALTH (PER SITE REPORTER): WAITING FOR THEIR RESPONSE.