MalfunctionMPO

CARDINAL HEALTH

Received Jul 23, 2024 · Event occurred Mar 26, 2024

Report 19805305 · MDR key 19805305

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Cardinal Health 200, Llc

Model number

11460-010T

Catalog number

11460-010T

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

REGISTERED NURSE (RN) WAS ATTEMPTING TO POP HEEL WARMER TO TAKE INFANT'S BLOOD GLUCOSE. HEEL WARMER RUPTURED AND CONTENTS WAS EXPELLED OUT OF HEEL WARMER BAG. CONTENTS OF BAG WAS NOT YET WARM, NO PHYSICAL INJURY NOTED. MANUFACTURER RESPONSE FOR INFANT HEEL WARMER (CHEMICAL HEAT PACK), CARDINAL HEALTH (PER SITE REPORTER). WE ISSUED AN INTERNAL RECALL ON THIS PROBLEM. IT HAS BEEN RESOLVED. JUST SUBMITTING THIS REPORT ON BEHALF OF THIS USER FACILITY.