inforMED
MalfunctionMPO

CARDINAL HEALTH

Received May 3, 2024 · Event occurred Mar 25, 2024

Report 19237324 · MDR key 19237324

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Lot number

VN23270A17

Patient

NA · Unknown

  • Chemical Exposure
  • Chemical Exposure

Narrative

Description of Event or Problem

TWO INFANT HEEL WARMERS FROM CARDINAL HEALTH FROM LOT#VN23270A17 HAVE EXPLODED WHEN THE REGISTERED NURSE (RN) WAS SQUEEZING THE PACKAGE TO ACTIVATE THE HEEL WARMER. ONE RN HAD THE SUBSTANCE IN THE WARMER LAND ON HER FACE AND SOME GOT INTO HER EYE. THE SECOND WARMER SUBSTANCE DID NOT GET ON THE NURSE, BUT DID SPRAY THE CHEMICAL SUBSTANCE ALL OVER THE WALL AND EQUIPMENT IN THE NURSERY. BOTH CIRCUMSTANCES HAD INFANTS WITH THE NURSE WHEN THE PACKAGES EXPLODED. ALL PACKAGES FROM THIS LOT NUMBER HAVE BEEN REMOVED FROM THE SUPPLY ON THE MOM/BABY UNIT. MANUFACTURER RESPONSE FOR INFANT HEEL WARMER (CHEMICAL HEAT PACK), CARDINAL HEALTH (PER SITE REPORTER). CARDINAL HAS LET US KNOW THE CONTENTS OF THE WARMER ARE NON-TOXIC SO THERE IS NO POTENTIAL FOR BURNS. CARDINAL WORKING WITH US TO ISSUE AN INTERNAL RECALL AND WILL TAKE THE PRODUCT BACK DUE TO QUALITY.