MalfunctionMPO
INFANT HEEL WARMER SQUEEZE 4X4IN
Received Jan 11, 2024 · Event occurred Feb 24, 2023
Report 1423537-2024-00003 · MDR key 18499856
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
UNKNOWN
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT WHILE HER SON WAS IN THE NICU, ONE OF THE STAFF MEMBERS SQUEEZED/TWISTED THE HEEL WARMER SO TIGHTLY THAT IT BUSTED AND SOME OF THE CONTENTS GOT ON HER SON AND HUSBAND. THERE WAS NO INJURY.
Additional Manufacturer Narrative
AS NO SAMPLES OR LOT NUMBER WERE PROVIDED FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. IF MORE INFORMATION IS PROVIDED AT A LATER DATE THE INVESTIGATION WILL BE REOPENED. CARDINAL HEALTH WILL CONTINUE TO MONITOR FOR THIS REPORTED ISSUE.