MalfunctionMPO

NOVAPLUS INFANT HEEL WARMER

Received Mar 28, 2023 · Event occurred Mar 22, 2023

Report MW5116039 · MDR key 16630204

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Cardinal Health 200, Llc.

Catalog number

V11460-010

Product problems

Leak/Splash
Device Difficult to Setup or Prepare
Material Rupture

Patient

1 DA · Female

Skin Inflammation/ Irritation
Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

THE NOVAPLUS INFANT HEEL WARMER PACKETS (TEAL/WHITE PACKAGING) IS "EXPLODING" WHEN ACTIVATED. WHEN SQUEEZED TO ACTIVATE THE CONTENTS, THE SEAL ON THE PACKAGING OPENS UP AND THE CONTENTS SPRAY ACROSS THE AREA. ONE STAFF HAS MADE CONTACT WITH HER SKIN AND CAUSED SOME IRRITATION. DEFECTIVE ITEM DID NOT REACH THE BABY. TEMPERATURE CONTROL.