INFANT HEEL WARMER SQUEEZE 4X4IN

Additional Manufacturer Narrative

NO SAMPLES WERE RECEIVED FOR EVALUATION THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE SAMPLES BECOME AVAILABLE AT A LATER DATE THE INVESTIGATION WILL BE REOPENED, AND FURTHER EVALUATION PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER REPORTED V3B229 WAS REVIEWED AND WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.

Description of Event or Problem

MEDWATCH REPORT (B)(4); IT HAS BEEN REPORTED THAT A HEEL WARMER BURST WHILE A NURSE WAS ACTIVATING. THE CONTENTS LANDED ON THE NURSE¿S CLOTHING AND ON THE FLOOR. THERE WAS NO INJURY REPORTED.