inforMED
MalfunctionMPO

INFANT HEEL WARMER,SQUEEZE, 4X4IN

Received May 25, 2022 · Event occurred Apr 28, 2022

Report 1423537-2022-00771 · MDR key 14493929

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

11460-010T

Catalog number

11460-010T

Lot number

V2C104

Product problems

  • Burst Container or Vessel
  • Burst Container or Vessel

Patient

Female

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

Narrative

Additional Manufacturer Narrative

DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2C104. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. ONE SAMPLE WAS RECEIVED FOR INVESTIGATION AND WAS ALREADY ACTIVATED. THE SAMPLE WAS INSPECTED FOR ANY DAMAGE OR DEFECTS; NO ISSUES WERE IDENTIFIED. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.

Description of Event or Problem

CUSTOMER REPORTED AN INFANT HEEL WARMER WAS LEAKING FROM THE SIDE SEAL AFTER ACTIVATION. THERE WAS EXPOSURE BUT FORTUNATELY, THE LAB TECH WAS WEARING GLOVES. NO INJURY REPORTED.