NOVAPLUS INFANT HEEL WARMER SQUEEZE

Description of Event or Problem

CUSTOMER REPORTED THAT PRODUCT FROM A BURST HOT PACK LANDED ON BABY'S FOREHEAD AFTER ACTIVATING TO PERFORM HEEL STICK. THE DEMOGRAPHICS FOR THE BABY ARE UNKNOWN. NO INJURY TO BABY.

Additional Manufacturer Narrative

WE RECEIVED NINETEEN SAMPLES FOR EVALUATION. UPON RECEIPT, ONE OUT OF THE NINETEEN WERE ALREADY ACTIVATED. THAT ONE EACH THAT WAS ACTIVATED WAS INSPECTED AND FAILURE MODE BURST/LEAK WAS UNABLE TO BE CONFIRMED VIA EVALUATION OF THE RETURNED DEVICE; THE PRODUCT WAS NOT LEAKING. THE REMAINING EIGHTEEN SAMPLES WERE ACTIVATED AND INSPECTED FOR FAILURE. FIVE SAMPLES LEAKED FROM THE TOP SEAL. THE ROOT CAUSE FOR THE NONCONFORMING PRODUCT WAS DETERMINED TO BE AN INCOMPLETE TOP SEAL. THE MACHINE WAS SETUP CORRECTLY AND IS DESIGNED WITH A MECHANISM WHICH REDUCES THE LIKELIHOOD FOR THIS ISSUE. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2S056. THE LOT 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 COMPLAINT TRENDS FOR THIS REPORTED ISSUE OF BURST AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.