MalfunctionMPO

NOVAPLUS INFANT HEEL WARMER

Received Apr 10, 2023 · Event occurred Apr 5, 2023

Report MW5116504 · MDR key 16713925

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Manufacturer

Cardinal Health 200, Llc.

Catalog number

V11460-010

Product problems

Burst Container or Vessel

Patient

Unknown

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

Narrative

Description of Event or Problem

WE HAVE HAD SEVERAL INSTANCES OF THE NOVAPLUS INFANT HEEL WARMER EXPLODING WHEN SQUEEZING FOR ACTIVATION, WHICH CAN RESULT IN INJURY TO STAFF AND/OR PATIENTS. IT IS UNCLEAR AT THIS TIME IF THIS IS ISOLATED TO A SPECIFIC LOT NUMBER.