PRE-KLENZ POINT OF USE GEL

Additional Manufacturer Narrative

THE PRE-KLENZ POINT OF USE GELS SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION AND FOUND THAT THE RIM ON THE CANS CAUSED THE GASKET NOT TO SEAL PROPERLY WHICH LOST PRESSURE OVER TIME RESULTING THE CANS NOT BEING ABLE TO SPRAY. STERIS EXPLAINED THAT THE CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO THE BAG-ON-VALVE CONFIGURATION; THE BAG OF PRE-KLENZ'S LIKELY CAME UNATTACHED FROM THE VALVE INSIDE THE PRESSURIZED CONTAINER. THIS CAN OCCUR WHEN A CAN OF PRODUCT IS DROPPED OR SHAKEN. THE PRE-KLENZ POINT OF USE PROCESSING GEL PRODUCT LABEL STATES: "AT POINT OF USE, PRESS AND DISPENSE GEL OVER SURGICAL TRAY OF INSTRUMENTS TO ENSURE SOILS ARE EVENLY COVERED." PRE-KLENZ POINT OF USE PROCESSING GEL IS NOT A MEDICAL DEVICE. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT DID NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING AN MDR SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR POLICIES AND PROCEDURES. THE DEVICE HISTORY RECORD FOR THE LOTS NUMBER SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THESE LOTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT (B)(4) THAT MULTIPLE OF THEIR PRE-KLENZ POINT OF USE GEL WOULD NOT SPRAY PROPERLY. NO REPORT OF INJURY.