INFANT HEEL WARMER,SQUEEZE, 4X4IN

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.

Additional Manufacturer Narrative

A SAMPLE WAS RECEIVED FOR EVALUATION AND THE INVESTIGATION DETERMINED THAT THE SAMPLE RECEIVED WAS ALREADY ACTIVATED BUT THE DEFECT REPORTED WAS UNCONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE SAMPLE HAD NO APPARENT DEFECTS AND WAS NOT FOUND TO BE LEAKING. DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT, 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.