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)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog 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.