INFANT HEEL WARMER SQUEEZE 4X4IN

Description of Event or Problem

IT IS REPORTED THAT A LAB TECH WAS PREPARING TO USE A CARDINAL HEALTH INFANT HEEL WARMING PACK. WHEN SHE SQUEEZED THE POUCH AS DIRECTED FOR USE THE PACK BURST IN HER FACE. THE CONTENTS WENT INTO HER RIGHT EYE, NOSE, AND MOUTH. SHE WAS IMMEDIATELY TAKEN TO THE EYE WASH STATION WHERE SHE CONTINUOUSLY RINSED THE EYE AS WELL AS RINSED HER MOUTH SEVERAL TIMES. THE REMAINING SUBSTANCE WAS WIPED FROM HER FACE, AND SHE WAS TRANSFERRED TO THE EMERGENCY ROOM. THE ISSUE RESULTED IN A SCRATCH ON HER EYE AND A FOLLOW UP WITH OPHTHALMOLOGY. SHE WAS GIVEN AN ANTIBIOTIC EYE DROP AND MISSED ONE DAY OF WORK. SHE IS DOING WELL AND THERE ARE NO RESIDUAL ISSUES.

Additional Manufacturer Narrative

THE COMPLAINT INDICATED THAT SAMPLES WERE NOT AVAILABLE. WITHOUT A SAMPLE THE ROOT CAUSE CANNOT BE DETERMINED. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V3B283. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORD. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.