inforMED
MalfunctionMPO

CARDINAL HEALTH

Received Sep 30, 2024 · Event occurred Jun 20, 2024

Report 20332428 · MDR key 20332428

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

[DATE REDACTED]: INFANT HEEL WARMER EXPLODED WHEN ACTIVATED, AND CONTENTS SPRAYED OVER THE NEONATE INTENSIVE CARE UNIT (NICU) NURSE. EMPLOYEE HEALTH AND NURSING LEADERSHIP NOTIFIED. [DATE REDACTED]: POSTPARTUM UNIT NURSE ATTEMPTED TO ACTIVATE INFANT HEEL WARMER (INSTANT SQUEEZE ACTIVATION). DURING ACTIVATION PROCESS, THE TOP PORTION OF THE PRODUCT SPLIT OPEN AND CONTENT SPLASHED IN THE EMPLOYEE¿S FACE AND EYES. NO PHYSICAL INJURIES REPORTED OR IDENTIFIED. THE EMPLOYEE¿S CONTACT LENSES WERE DAMAGED. EMPLOYEE HEALTH AND NURSING LEADERSHIP NOTIFIED.