INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER, V2C235. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON (B)(6) 2022 AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO SAMPLES WERE RETURNED FOR EVALUATION THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.

Description of Event or Problem

INFORMATION RECEIVED FROM MDR REPORT NUMBER: (B)(4). DURING THE ADMISSION OF A BABY TO THE SPECIAL CARE NURSERY A HEEL WARMER WAS OBTAINED, WHEN SQUEEZING THE HEEL WARMER TO ACTIVATE IT TO PLACE ON PATIENT, THE WARMER EXPLODED IN MY HAND WHICH CAUSED THE CONTENT INSIDE TO SPRAY ACROSS ROOM. THE CONTENT CAME INTO CONTACT AND LANDED ON A BABY. THE BABY WAS CLEANED IMMEDIATELY WITH SOAP AND WATER. SKIN WAS ASSESSED NO EVIDENCE NOTED OF ANY REACTION OR REDNESS. NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED AND CONTINUED TO MONITOR BABY. FDA SAFETY REPORT. ID# (B)(6).