INFANT HEEL WARMER

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (B)(4) WAS RECEIVED INDICATING THAT A HEEL WARMER HAD A SMALL HOLE IN IT AND, UPON ACTIVATION, EXPOSED A NURSE TO LIQUID THAT CAUSED MINOR SKIN IRRITATION. A SAMPLE WAS NOT AVAILABLE FOR RETURN. THIS INCIDENT IS CURRENTLY UNDER INVESTIGATION. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

Description of Event or Problem

WHEN THE HEEL WARMER WAS ACTIVATED, A SMALL HOLE WAS NOTICED ON THE CORNER OF THE DEVICE. AS IT HEATED UP, IT EXPLODED AND DROPS OF THE LIQUID HIT THE NURSES CHEST AND FACE. THE SITES OF THESE DROPS LATER TURNED RED.

Description of Event or Problem

WHEN THE HEEL WARMER WAS ACTIVATED, A SMALL HOLE WAS NOTICED ON THE CORNER OF THE DEVICE. AS IT HEATED UP, IT EXPLODED AND DROPS OF THE LIQUID HIT THE NURSES CHEST AND FACE. THE SITES OF THESE DROPS LATER TURNED RED.

Additional Manufacturer Narrative

ROOT CAUSE: THE TRUE ROOT CAUSE COULD NOT BE DETERMINED. THE ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION, AND NO DISCREPANCIES WERE FOUND DURING INVENTORY CHECK OR REVIEW OF THE WORK ORDER AND RAW MATERIAL. CORRECTIVE ACTION: DUE TO THE INVESTIGATION FINDINGS AND ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT A HEEL WARMER HAD A SMALL HOLE IN IT AND, UPON ACTIVATION, EXPOSED A NURSE TO LIQUID THAT CAUSED MINOR SKIN IRRITATION. A SAMPLE WAS NOT AVAILABLE FOR RETURN. AN INVENTORY CHECK WAS CONDUCTED AND NO EVIDENCE OF THE REPORTED ISSUE WAS FOUND. THE WORK ORDER WAS REVIEWED FOR ANY DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. DEROYAL PERSONNEL PERFORM A VISUAL INSPECTION DURING THE MANUFACTURING PROCESS. ADDITIONALLY, FIVE EACH OF THE PRODUCT ARE ACTIVATED FOR TESTING FOR EACH BATCH THAT IS PRODUCED. NO DISCREPANCIES WERE FOUND DURING THE ACTIVATION AND TESTING OF THE PRODUCT. THE COMPLAINT INVESTIGATOR CHECKED TWO LOTS (47059288 AND 47017598) DURING THE MANUFACTURING PROCESS AND CHECKED RAW MATERIAL PART 624817, WHICH IS THE MATERIAL USED TO MAKE THE OUTER BAG OF THE HEEL WARMER. NO DISCREPANCIES WERE FOUND DURING THESE INSPECTIONS. DEROYAL HAS SOLD (B)(4) EACHES OF THE FINISHED GOOD SINCE SEPTEMBER 2016. THE COMPLAINT-TO-SALES RATIO FOR THIS SAME TIME PERIOD IS 0.0007. PREVENTIVE ACTION: DUE TO THE INVESTIGATION FINDINGS AND ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.