NOVAPLUS INFANT HEEL WARMER SQUEEZE

Additional Manufacturer Narrative

THE ACTUAL COMPLAINT SAMPLE WAS DISCARDED BY THE CUSTOMER, BUT TWO UN-USED SAMPLES FOR LOT NUMBER V3C124 WERE RECEIVED FOR INVESTIGATION. THE UN-USED SAMPLES WERE VISUALLY INSPECTED, AND NO DEFECT WAS IDENTIFIED. THE SAMPLES WERE THEN ACTIVATED AS INTENDED AND DID NOT BURST OR LEAK, AND NO DEFECT WAS IDENTIFIED. THEREFORE, THE FAILURE MODE CANNOT BE CONFIRMED BASED ON EVALUATION OF THE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED ON THE RETURNED LOT NUMBER, V3C124. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS AND NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS REPORTED ISSUE.

Description of Event or Problem

CUSTOMER REPORTED THE NOVA PLUS HEEL WARMER BURST THROUGH THE PACKAGING WHEN ACTIVATED. THE LIQUID GEL DEBRIS FROM HEEL WARMER PACK SPLATTERED ON INFANT PATIENT. THE DEBRIS WAS WIPED OFF THE INFANT AND THE HEAL WARMER WAS DISCARDED. NO INJURY REPORTED.