INFANT HEEL WARMER SQUEEZE 4X4IN
Received Aug 15, 2023 · Event occurred Jul 14, 2023
Report 1423537-2023-00980 · MDR key 17552982
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Mo016 Mo-moberlyModel number
11460-010TCatalog number
11460-010T
Lot number
VSD237
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
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 THAT THEY HAD TWO MORE HEEL WARMERS/HEAT PACKS BURST. NO PATIENTS OR EMPLOYEES WERE INJURED OR SPRAYED WITH THE INTERNAL CONTENTS OF THE HEAT PACK. AFTER THE INCIDENT, THE STAFF WENT THROUGH ALL OF THE WARMERS AND FOUND MORE PACKS WITH OPEN OUTER SEAMS AND PULLED THEM OUT OF SERVICE.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION AND THE DEFECT REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A SMALL HOLE IN THE OUTER POUCH DUE TO IMPROPER MACHINE SETUP. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT VSD237, AND THE LOT WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. CARDINAL HEALTH HAS MADE A BUSINESS DECISION TO CLOSE THE SITE WHICH MANUFACTURES PRODUCT 11460-010T AND TRANSITION TO A THIRD-PARTY MANUFACTURER.