INFANT HEEL WARMER SQUEEZE 4X4IN

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 V3E024, 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.

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 ¿IN THE NICU, THIS PRODUCT IS EXPLODING WHEN ACTIVATED. IT EXPLODED ONTO SEVERAL STAFF MEMBERS, POTENTIALLY CAUSING HARM TO A FEW. THE PACK CONTENTS CAME IN CONTACT WITH RN¿S EYES. I HAVE SOME OF THE EXPLODED PRODUCT IN MY OFFICE. WE HAVE REMOVED THE LOT NUMBER FROM THE FLOORS AND PATIENT ROOMS. A PROVIDER ON OUR UNIT INSPECTED HER EYES. EYE WASH DONE. ALL STAFF MEMBERS APPEAR TO BE DOING FINE. NO RESIDUAL COMPLAINTS NOTED¿.