INFANT HEEL WARMER SQUEEZE 4X4IN

Description of Event or Problem

IT HAS BEEN REPORTED THAT A LABORATORY SUPPORT TECHNICIAN WAS ACTIVATING THE HEEL WARMER BY SQUEEZING IT, THE TOP OF THE HEEL WARMER BUSTED OPEN. THERE WAS NO INJURY/ADVERSE EVENT. THE PACK MATERIAL GOT ON THE CLINICIAN'S CLOTHES. THERE WAS NO SKIN CONTACT. IT WAS WASHED AWAY WITH SOAP AND WATER. THE CLINICIAN WAS NOT HARMED.

Additional Manufacturer Narrative

TWO SAMPLES WERE RECEIVED FOR EVALUATION AND WERE VISUALLY INSPECTED FOR ANY DEFECTS. THE SAMPLES WERE ALREADY ACTIVATED AND A TEAR WAS NOTED IN POUCH. THE ROOT CAUSE WHICH CONTRIBUTED TO THE TEAR WAS DUE TO A MACHINE MISALIGNMENT. THE DEVICE HISTORY RECORD OF THE COMPLAINT LOT WAS REVIEWED. THE LOT WAS INSPECTED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. CARDINAL HEALTH WILL CONTINUE TO MONITOR AND TREND ALL SIMILAR REPORTED PRODUCT RELATED ISSUES.