INFANT HEEL WARMER SQUEEZE 4X4IN

Description of Event or Problem

MW: (B)(4). EMPLOYEE ¿CRACKED¿ THE HEEL WARMER, PER INSTRUCTIONS. THE HEEL WARMERS CONTENTS EXPLODED OUT OF THE TOP AND LANDED ON EMPLOYEE. THIS INCLUDED THE CONTENT GETTING INTO HER RIGHT EYE. THE EMPLOYEE WAS SEEN BY EMPLOYEE HEALTH AND CLEARED TO RETURN TO WORK.

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.

Additional Manufacturer Narrative

SEE RELATED MEDWATCH REPORT NUMBER (B)(4) IN H10. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SUPPLEMENTAL REPORT IS BEING FILED SINCE THE RELATED REPORT NUMBER (B)(4) WAS NOT ORIGINALLY INCLUDED IN THE CORRESPONDING BLOCK H RELATE REPORT NUMBER FIELD OF MEDICAL DEVICE REPORT NUMBER 1423537-2024-00020 DATED (06/01/2024). 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.

Additional Manufacturer Narrative

RELATED MEDWATCH REPORT NUMBER 2100230000-2024-8004. FOLLOW UP REPORT BEING FILED SINCE THE INVESTIGATION HAS BEEN COMPLETED. ACTUAL SAMPLE WAS NOT RETURNED FOR INVESTIGATION AFTER MULTIPLE REQUESTS TO THE CUSTOMER. THEREFORE, THE ROOT CAUSE FOR CRACK IN INFANT HEEL WARMER COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.