inforMED
InjuryMPO

MEDLINE INFANT HEEL WARMER

Received Feb 17, 2023 · Event occurred Feb 2, 2023

Report MW5115080 · MDR key 16411814

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Product problems

  • Gel Leak
  • Device Difficult to Setup or Prepare
  • Material Rupture

Patient

1 DA · Male

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

Narrative

Description of Event or Problem

PRIMARY RN WAS COLLECTING A POC (POINT-OF-CARE) GLUCOSE ON AN INFANT WHEN SHE ATTEMPTED TO USE A MEDLINE INFANT HEEL WARMER BY BREAKING THE INNER COMPONENT TO START THE WARMING. HOWEVER, THE HEEL WARMER SPLIT THROUGH THE OUTSIDE BAG, SPILLING WARM GEL OUT. IT DID NOT EVER TOUCH THE INFANT. DEFECTIVE WARMER WAS SET ASIDE IN A PLASTIC BAG KEPT AT THE NURSES' STATION.