INFANT HEEL WARMER,SQUEEZE, 4X4IN

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V1D033. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. PHOTOS OF THE AFFECTED PRODUCT WERE PROVIDED; HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE PHOTOS. WITHOUT A SPECIFIC ASSIGNABLE CAUSE, NO SPECIFIC CORRECTIVE ACTIONS CAN BE COMPLETED; HOWEVER, WE WILL CONTINUE TO MONITOR THIS FAILURE MODE FOR THIS PRODUCT.

Description of Event or Problem

CUSTOMER REPORTED THAT THE HEEL WARMER BROKE WHEN THE PRODUCT WAS SQUEEZED TO ACTIVATE WARMER. CONTENTS STAINED THE FLOOR, PANTS OF PATIENT AND PANTS OF THE NURSE. NO INJURY REPORTED.

Additional Manufacturer Narrative

SUPPLEMENTAL REPORT IS BEING FILED FOLLOWING THE SUBMISSION OF THE INITIAL MDR REPORT SINCE AN INFANT HEEL WARMER PRODUCT NUMBER 11460-010T WAS RETURNED FOR INVESTIGATION.. DEVICE HISTORY REVIEW WAS COMPLETED ON THE REPORTED LOT V1D033. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. WE RECEIVED 1 SAMPLE ON 2/1/2022. THE SAMPLE WAS ALREADY ACTIVATED. THE ROOT CAUSE WAS DETERMINED TO BE VOIDS IN THE SIDE SEAL DUE TO INADEQUATE PROCEDURE. THE PROCEDURE WILL BE UPDATED TO DOCUMENT SEAL RUBBER CHANGES ON THE POUCH MACHINE. ADDITIONALLY, THE SITE WILL CONTINUE TO MONITOR COMPLAINT TRENDS.