INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED FOR EVALUATION AND THE INVESTIGATION DETERMINED THAT THE SAMPLE RECEIVED WAS ALREADY ACTIVATED AND DEFECT REPORTED WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE AN INCOMPLETE TOP SEAL DUE TO IMPROPER MACHINE SETUP. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT V2P263E, AND THE LOT WAS MANUFACTURED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. 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.

Description of Event or Problem

NIGHT SHIFT NICU RN OPENED AN INFANT HEEL WARMER AND IT DID NOT ACTIVATE. THE POWDER CAME OUT THROUGH THE TOP AND GOT IN THE RN'S EYE. SHIFT SUPERVISOR WAS NOTIFIED AND CALLED POISON CONTROL FOR INSTRUCTION ON EXPOSURE. RN FLUSHED EYE AT TIME OF CONTACT AND USED ARTIFICIAL TEARS FOR TREATMENT. RN HAVING NO PAIN OR FURTHER COMPLICATIONS.