MalfunctionMPO

CARDINAL HEALTH

Received May 3, 2024 · Event occurred Apr 8, 2024

Report 19237147 · MDR key 19237147

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Cardinal Health 200, Llc

Model number

11460-010T

Catalog number

11460-010T

Lot number

VN22349A9

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

WHILE EMPLOYEE SQUEEZED AND ACTIVATED THE INFANT HEEL WARMER, THE PRODUCT GOT COLDER INSTEAD OF WARMER. THE CONTENTS HAD A GRITTY FEELING INSIDE AFTER ACTIVATING.