INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 24, 2022 · Event occurred Jun 22, 2022
Report 1423537-2022-00825 · MDR key 15287646
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C235
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
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER, V2C235. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON 3/23/22 AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR EVALUATION THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.
Description of Event or Problem
INFORMATION RECEIVED FROM MDR REPORT NUMBER: MW5110974. DURING THE ADMISSION OF A BABY TO THE SPECIAL CARE NURSERY A HEEL WARMER WAS OBTAINED, WHEN SQUEEZING THE HEEL WARMER TO ACTIVATE IT TO PLACE ON PATIENT, THE WARMER EXPLODED IN MY HAND WHICH CAUSED THE CONTENT INSIDE TO SPRAY ACROSS ROOM. FDA SAFETY REPORT. ID# (B)(4).