INFANT HEEL WARMER SQUEEZE 4X4IN

Additional Manufacturer Narrative

DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V3A209. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR INVESTIGATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE OF BURST AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.

Description of Event or Problem

CUSTOMER REPORTED ¿THE INFANT HEEL WARMER POPPED RECENTLY, BURSTING ON THE NURSE'S INTACT SKIN OF HANDS AND ON FLOOR. THERE WAS NO INJURY AND THE NURSE IS FINE¿.