3M STERI-VAC(TM) GAS STERILIZER/AERATOR

Additional Manufacturer Narrative

THE REPORT INDICATED FEMALE IN THEIR 30'S. SPECIFIC INFORMATION ON THE SERIAL NUMBER WAS NOT PROVIDED WITHIN THE SYSTEM REPORT. WITHOUT THIS INFORMATION IT IS NO POSSIBLE TO PROVIDE A MANUFACTURER DATE. IN FOLLOW-UP WITH THE SERVICE DEPARTMENT THERE WAS A STRONG INDICATION THE STERILIZER WAS FUNCTIONING AND MET SPECIFICATION. IT APPEARS THE CANISTER MAY NOT HAVE BEEN INSTALLED CORRECTLY INTO THE STERILIZER BY THE USER THEREFORE, RESULTING IN ITS DIFFICULTY IN REMOVAL AND THE REMAINING RESIDUAL EO LIQUID. THIS REPORT IS CONCERNING A CO-WORKER WHO WAS IN THE AREA AT THE TIME. REPORT 2110898-2016-00026 WAS SENT TO THE FDA REGARDING THE USER WHO ACTUALLY REMOVED THE CANISTER FROM THE STERILIZER.

Description of Event or Problem

A FEMALE EMPLOYEE IN HER 30S WAS WORKING NEAR A 3M STERI-VAC (TM) GAS STERILIZER/AERATOR (MODEL 4XL) ON (B)(6) 2016. ERROR CODES DISPLAYED ON THE STERILIZER SCREEN; THE STERILIZER WAS IN AERATION MODE. A CO-WORKER OPENED THE DOOR OF THE STERILIZER AND REMOVED THE CANISTER OF ETHYLENE OXIDE FROM THE STERILIZER AND TOSSED IT ON THE FLOOR. THE ETHYLENE OXIDE ALARM SOUNDED IN THE ROOM. THE WOMAN ALLEGED SHE MAY HAVE FELT A DROPLET OF LIQUID ON HER CHEEK UNDER HER LEFT EYE WHEN THE CO-WORKER REMOVED THE CANISTER. SHE SHOWERED IMMEDIATELY AND WAS TAKEN BY AMBULANCE TO THE FACILITY'S OCCUPATIONAL MEDICAL CLINIC. SHE SHOWERED AGAIN FOR 15 MINUTES AND WAS EVALUATED BY A PHYSICIAN. NO MARKS WERE NOTED. THE FEMALE EMPLOYEE WAS SEEN IN THE CLINIC THE NEXT DAY. A RED MARK WAS NOTED BELOW HER LEFT EYE. NO MEDICAL TREATMENT WAS SPECIFIED. THE RED MARK RESOLVED WITHIN TWO DAYS.