INFANT HEEL WARMER SQUEEZE 4X4IN

Description of Event or Problem

KAISER INFUSION CENTER NURSE WAS PREPARING THE CARDINAL HEALTH INFANT HEEL WARMER PER PRODUCT INSTRUCTIONS WHEN THE PRODUCT BURST OPEN, AND CONTENTS LEAKED UNTO HIS UPPER THIGHS. THANKFULLY, THE CONTENTS ONLY CAME IN CONTACT WITH HIS SCRUBS. HE REMOVED HIS SCRUBS AND IS DOING WELL. NO INJURY REPORTED.

Additional Manufacturer Narrative

DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V2P009. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. ONE PRE-ACTIVATED SAMPLE WAS RECEIVED FOR EVALUATION AND SHOWED A CUT IN THE POUCH. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BUT WAS MOST LIKELY NOT DUE TO THE MANUFACTURING PROCESS. THE PRODUCT SHIPPER DOES INDICATE ¿DO NOT USE A SHARP KNIFE¿ WHEN OPENING THE CASE TO AVOID ANY DAMAGE TO THE PRODUCT. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.