INFANT HEEL WARMER SQUEEZE 4X4IN
Received Jul 25, 2023 · Event occurred Jun 29, 2023
Report 1423537-2023-00971 · MDR key 17393916
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
UNKNOWN
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
AS NO SAMPLES WERE RETURNED FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CARDINAL HEALTH HAS MADE A BUSINESS DECISION TO CLOSE THE SITE WHICH MANUFACTURES PRODUCT 11460-010T AND TRANSITION TO A THIRD-PARTY MANUFACTURER.
Additional Manufacturer Narrative
THE COMPLAINT WAS FORWARDED TO THE MANUFACTURING FACILITY WHERE IT IS CURRENTLY STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.
Description of Event or Problem
CUSTOMER REPORTED, STAFF MEMBER SQUEEZED NEWBORN HEEL WARMER TO ACTIVATE AND THE GEL LEAKED OUT. IMMEDIATELY UPON SQUEEZING, THE PRODUCT PACKAGING SEPARATED ALONG AN EDGE CAUSING A HOLE AND INNER CONTENTS TO LEAK OUT. CUSTOMER FEARS STAFF OR PATIENT COULD BE HURT FROM WARMER LEAKING OUT. NO INJURY TO PATIENT OR STAFF FOR THIS INCIDENT.