NOVAPLUS INFANT HEEL WARMER 4X4IN
Received Mar 15, 2023 · Event occurred Feb 16, 2023
Report 1423537-2023-00884 · MDR key 16546943
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
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE NURSE WAS SQUEEZING THE PRODUCT IN HER HAND WHEN IT EXPLODED HITTING HER IN THE FACE, BUT SHE HAD GLASSES ON. THERE WAS NO HARM TO STAFF. SOAP AND WATER WERE USED TO REMOVE THE PRODUCT FROM THE SKIN.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION AND THE INVESTIGATION DETERMINED THAT THE SAMPLE RECEIVED WAS ALREADY ACTIVATED AND DEFECT REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE AN INCOMPLETE TOP SEAL DUE TO IMPROPER MACHINE SETUP. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056, AND THE LOT WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE OF BURST AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.