NOVAPLUS INFANT HEEL WARMER 4X4IN

Description of Event or Problem

CUSTOMER HAS REPORTED A PRODUCT CONCERN WITH CARDINAL HEALTH HEEL WARMERS THAT ARE RUPTURING DURING ACTIVATION. AND LANDED ON THE SKIN AND HAIR OF RN'S, PARENTS OF BABIES, AND ONTO CRIBS AND ISOLETTES. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED AND NO SPECIFIC DATA WAS PROVIDED UPON REQUEST.

Additional Manufacturer Narrative

EIGHT SAMPLES WERE RECEIVED. THE EVALUATION AND INVESTIGATION DETERMINED THAT THE SAMPLE RECEIVED WAS ALREADY ACTIVATED AND DEFECT REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A BURST PACK DUE TO 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 LEAK AND WORK TO IDENTIFY IMPROVEMENT ACTIVITIES TO MINIMIZE REOCCURRENCE.