NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received May 1, 2023 · Event occurred Apr 5, 2023
Report 1423537-2023-00921 · MDR key 16845834
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
V11460-010Catalog number
V11460-010
Lot number
V2S056
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Female
- Discomfort
- No Clinical Signs, Symptoms or Conditions
- Discomfort
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. SAMPLES WERE NOT RETURNED FOR EVALUATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.
Description of Event or Problem
CUSTOMER REPORTED THE INFANT HEEL WARMER RUPTURE/EXPLODED WHILE ACTIVATING AND THE CONTENTS WENT EVERYWHERE. ONE NURSE GOT IT IN HER EYES CAUSING BURNING AND HAD TO USE THE EYE WASH STATION TO RINSE OUT HER EYES. NO INJURY OR MEDICATION PROVIDED, AND THE NURSE IS DOING WELL. NO DEMOGRAPHICS PROVIDED.