INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Jul 1, 2022 · Event occurred Jun 3, 2022
Report 1423537-2022-00797 · MDR key 14887987
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200 LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C235D
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
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE HAS BEEN AN INCIDENT OF INFANT HEEL WARMER BURSTING DURING ACTIVATION. THEY HAVE IDENTIFIED THAT THE AFFECTED HEEL WARMER WAS LOT NUMBER V2C235D. THEY ARE REMOVING ADDITIONAL PRODUCT WITH THIS LOT NUMBER FROM THEIR INVENTORY. NO PATIENT DEMOGRAPHICS OR OTHER INFORMATION PROVIDED.
Additional Manufacturer Narrative
THE DEVICE HISTORY REVIEW(DHR) 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 INVESTIGATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS.