INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received May 28, 2022 · Event occurred May 2, 2022
Report 1423537-2022-00775 · MDR key 14538672
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2B110
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
26 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER HAS REPORTED THAT THE HEEL WARMER BUSTED OPEN BEFORE PLACING IT ON THE PATIENT. NO INJURY, THE HEEL WARMER WAS THROWN IN THE TRASH WITHOUT INCIDENT.
Additional Manufacturer Narrative
SUPPLEMENTAL REPORT IS BEING FILED SINCE DATA FOR SECTION H10 WAS MISSING IN THE ORIGINAL SUBMISSION. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER, V2B110. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON FEBRUARY 10, 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.