STERRAD® 100NX CASSETTE

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE NUMBER: (B)(4). MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER EVENT DETAILS WERE RECEIVED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ASP COMPLAINT REF #: (B)(4).

Description of Event or Problem

A CUSTOMER REPORTED A HEALTH CARE WORKER (HCW) CAME IN CONTACT WITH HYDROGEN PEROXIDE WHILE INSERTING A NEW STERRAD® 100NX CASSETTE WITHOUT WEARING GLOVES. THE HCW EXPERIENCED SKIN REACTIONS DESCRIBED AS ITCHINESS AND WHITE SKIN DISCOLORATION ON TWO FINGERS. IT WAS REPORTED THE HCW WENT TO THE EMERGENCY ROOM; HOWEVER, IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE AT THE TIME OF THIS REPORT, THE H2O2 SKIN REACTION WAS ASSESSED TO BE MINOR INJURY; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

Additional Manufacturer Narrative

ASP INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD COULD NOT BE REVIEWED DUE TO UNKNOWN LOT NUMBER. TRENDING ANALYSIS COULD NOT BE CONDUCTED DUE TO UNKNOWN LOT NUMBER. REVIEW OF RISK DOCUMENTATION SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." THE INVOLVED STERRAD® 100NX CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, NO FURTHER PRODUCT EVALUATION OR SUPPLIER INVESTIGATION CAN BE COMPLETED. THE MOST LIKELY ASSIGNABLE CAUSE FOR THE SKIN REACTION CAN BE ATTRIBUTED TO USER NOT FOLLOWING THE STERRAD® 100NX USER GUIDE FOR PROPER HANDLING OF CASSETTES. THE CUSTOMER WAS RETRAINED TO ALWAYS WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN WORKING WITH THE STERILIZER AS PER THE STERRAD® 100NX USER GUIDE: - ¿AS A PRECAUTION, WHEN HANDLING ANY PART OF THE SYSTEM OR LOAD ITEMS THAT HAVE BEEN EXPOSED TO HYDROGEN PEROXIDE, PLEASE WEAR THE APPROPRIATE PPE (CHEMICAL RESISTANT LATEX, PVC/VINYL, OR NITRILE GLOVES).¿ ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).