MINNCARE HD

Additional Manufacturer Narrative

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, IT WAS DISCOVERED THAT THE BOTTLES SUBJECT OF THE REPORTED EVENT WERE CRACKED AND MAY HAVE BEEN DROPPED. ADDITIONALLY, IT WAS DISCOVERED THAT THE BOTTLES EXPIRED IN AUGUST 2024 AND THAT USER FACILITY PERSONNEL WERE WEARING SURGICAL MASKS WHILE CLEANING UP THE SPILL. THE MINNCARE HD DISINFECTANT SDS STATES, "IN CASE OF INSUFFICIENT VENTILATION, WEAR SUITABLE RESPIRATORY EQUIPMENT. RESPIRATOR SELECTION MUST BE BASED ON KNOWN OR ANTICIPATED EXPOSURE LEVELS, THE HAZARDS OF THE PRODUCT AND THE SAFE WORKING LIMITS OF THE SELECTED RESPIRATOR." THE SDS FURTHER STATES, "KEEP ONLY IN ORIGINAL CONTAINER. USE ONLY OUTDOORS OR IN A WELL-VENTILATED AREA. DO NOT BREATHE DUSTS OR MISTS. STORE IN A WELL-VENTILATED PLACE. KEEP CONTAINER TIGHTLY CLOSED. STORE LOCKED UP. DISPOSE OF CONTENTS/CONTAINER IN ACCORDANCE WITH LOCAL/REGIONAL/NATIONAL/INTERNATIONAL REGULATIONS." STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER HANDLING AND STORAGE OF MINNCARE HD DISINFECTANT, HOWEVER THE USER FACILITY DECLINED. A 2-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED VIA CHEMTREC REPORT THAT FIVE EMPLOYEES EXPERIENCED INHALATION/IRRITATION EFFECTS WHILE CLEANING UP DISINFECTANT THAT HAD LEAKED FROM TWO BOTTLES OF MINNCARE HD DISINFECTANT INSIDE A CLOSET. THE EMPLOYEES DID NOT SEEK MEDICAL TREATMENT.