INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 24, 2022 · Event occurred Jun 8, 2022
Report 1423537-2022-00826 · MDR key 15287772
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 (DHR) WAS COMPLETED ON THE REPORTED LOT V2C235. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR EVALUATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS PRODUCT.
Description of Event or Problem
CUSTOMER REPORTED THAT BEFORE CHECKING THE BABY'S BLOOD SUGAR, THE HEEL WARMER POPPED OPEN AND CONTENTS SPLATTERED ON SINK AND ACCU-CHEK MACHINE. CONTENTS DID NOT REACH PATIENT OR STAFF MEMBER. REPORT BEING FILED FOR POTENTIAL RISK.