INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received May 28, 2022 · Event occurred May 3, 2022
Report 1423537-2022-00774 · MDR key 14538670
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2C242
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
CUSTOMER HAS REPORTED HAVING INFANT HEEL WARMERS BUSTED DURING ACTIVATION AND GETTING THE CONTENTS ONTO PATIENTS, SPECIFICALLY BABIES. NO INJURY REPORTED. NO DEMOGRAPHICS OR OTHER ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER V2C242. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON MARCH 24, 2022, 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.