NOVAPLUS INFANT HEEL WARMER SQUEEZE
Received May 27, 2023 · Event occurred May 4, 2023
Report 1423537-2023-00941 · MDR key 17015412
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
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ACTUAL COMPLAINT SAMPLE WAS DISCARDED BY THE CUSTOMER; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED ON THE REPORTED LOT NUMBER, V2S056. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS AND NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.
Description of Event or Problem
CUSTOMER REPORTED THE NOVA PLUS HEEL WARMER BURST THROUGH THE PACKAGING WHEN ACTIVATED. THE LIQUID GEL DEBRIS FROM HEEL WARMER PACK SPLATTERED ON STAFF MEMBER. THE DEBRIS WAS WIPED OFF THE STAFF MEMBER AND THE HEAL WARMER WAS DISCARDED. NO INJURY REPORTED.