INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V2C242. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. SAMPLE WAS NOT RETURNED FOR EVALUATION DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.

Description of Event or Problem

CUSTOMER REPORTED THAT INFANT HEEL WARMER POPPED OPEN AT THE SEAL UPON ACTIVATION. NO ADVERSE EVENT WAS REPORTED. EVENT DATE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SUBMITTED ON 6/7/2022 SINCE THE RESULTS OF INVESTIGATION ARE AVAILABLE . DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2C242. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. WE RECEIVED 1 SAMPLE FOR EVALUATION. THE SAMPLE WAS ALREADY ACTIVATED. FROM THE INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE AN INCOMPLETE TOP SEAL. THIS WAS DETERMINED TO BE DUE TO SETUP ISSUES RESULTING FROM AN INADEQUATE PROCEDURE. A QUALITY ALERT WAS POSTED AND TRAINED ON TO ENSURE THE SETUP WAS DONE PROPERLY ON THE INFANT HEEL WARMER LINE. STANDARD PRODUCTION METHODS WILL BE UPDATED. CARDINAL WILL CONTINUE TO MONITOR TRENDS FOR THIS PRODUCT.