INFANT HEEL WARMER

Description of Event or Problem

PHLEBOTOMIST IS ACTIVATING THE HEEL WARMER TO USE TO WARM PATIENT HAND. WHEN SHE WAS SQUEEZING IT, IT BURST AND EXPLODED TO HER RIGHT EYE. PHLEBOTOMIST SENT TO ER FOR TREATMENT. NO AFTER EFFECTS NOTED PER THEIR EMAIL.

Additional Manufacturer Narrative

A USER FACILITY COMPLAINT WAS RECEIVED ON 1/20/2023, REPORTING, "PHLEBOTOMIST IS ACTIVATING THE HEEL WARMER TO USE TO WARM PATIENT HAND. WHEN SHE WAS SQUEEZING IT, IT BURST AND EXPLODED TO HER RIGHT EYE. PHLEBOTOMIST SENT TO ER FOR TREATMENT." THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION.

Additional Manufacturer Narrative

THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION AS IT HAD BEEN DISCARDED. DEROYAL INDUSTRIES INSPECTED (B)(4) CASES OF HNICU-100 FROM THE SAME LOT AS THE COMPLAINT PRODUCT AND FOUND NO ISSUES. INSTRUCTIONS FOR USE, PRODUCTION RECORDS, AND FAILURE MODES AND EFFECTS ANALYSIS (FMEA) WERE REVIEWED AND NO DISCREPANCIES OR GAPS WERE FOUND. FROM FEBRUARY 2022 TO PRESENT, DEROYAL HAS SOLD (B)(4) EACHES OF HNICU-100 WITH A TOTAL OF (B)(4) COMPLAINTS IN THAT TIME FRAME. THIS IS EQUATES TO A RATIO OF (B)(4). ROOT CAUSE: WAS DETERMINED TO BE UNKNOWN BY DEROYAL INDUSTRIES AS THE INVESTIGATION COULD NOT FIND ANY EVIDENCE OF THE REPORTED PROBLEM. POTENTIAL ROOT CAUSE DETERMINED BY DEROYAL: WHILE THE TRUE ROOT CAUSE COULD NOT BE DETERMINED, THE POTENTIAL ROOT CAUSE COULD BE, BUT IS NOT LIMITED TO, A MATERIAL DEFECT OR AN END USER ERROR. WHILE THERE WERE NO SPECIFIC CORRECTIVE OR PREVENTATIVE ACTIONS TAKEN, DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.