INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jun 16, 2022 · Event occurred May 26, 2022
Report 1423537-2022-00791 · MDR key 14715078
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 AND RELEASED TO PREDETERMINED SPECIFICATIONS AND NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR INVESTIGATION, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS.
Description of Event or Problem
IT HAS BEEN REPORTED THAT WHEN THE STAFF WENT TO ACTIVATE THE HEEL WARMERS THE PACKS WOULD BURST FROM THE TOP. THERE WAS NO INJURY TO STAFF MEMBERS.