STERRAD(R) 100NX(TM) 1-DR

Additional Manufacturer Narrative

ASP INVESTIGATION SUMMARY: DEVICE HISTORY RECORD REVIEW OF THE UNIT CANNOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. PRODUCT ANALYSIS WAS NOT PERFORMED, AS THE SERIAL NUMBER OF THE SUSPECT PRODUCT IS NOT KNOWN. COMPLAINT HISTORY OF THE UNIT INVOLVED CANNOT BE PERFORMED AS THE SERIAL NUMBER WAS NOT PROVIDED. THE SRA INDICATES THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL IS "LOW." ASSIGNABLE CAUSE: THE MOST LIKELY ASSIGNABLE CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED, SINCE THE FACILITY NAME AND SERIAL NUMBER OF THE UNIT WERE NOT PROVIDED. THE REPORTER REQUESTED ANONYMITY AND THE ISSUE COULD NOT BE CONFIRMED. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. 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

ADVANCED STERILIZATION PRODUCTS (ASP) RECEIVED A VOLUNTARY MEDWATCH REPORT FROM THE FDA ON MARCH 12, 2026. IT WAS REPORTED BY A FAMILY MEMBER, A HEALTH CARE WORKER (HCW) IN THE UNITED STATES EXPERIENCED RESPIRATORY SYMPTOMS ON (B)(6) 2026, WHEN HE WAS EXPOSED TO VAPOR/CHEMICAL EMISSIONS WHILE OPERATING OR WORKING NEAR A STERRAD 100NX STERILIZER. IT WAS ALLEGED HE WAS EXPOSED TO FUMES RELEASED FROM THE UNIT OR SURROUNDING AREA, AND SHORTLY AFTER EXPOSURE HE DEVELOPED CHEST TIGHTNESS, COUGHING, SHORTNESS OF BREATH, AND LUNG IRRITATION. IT WAS REPORTED HIS SYMPTOMS PERSISTED AND REQUIRED MEDICAL EVALUATION; HOWEVER, IT WAS NOT REPORTED WHAT TYPE OF MEDICAL TREATMENT WAS RECEIVED. MEDICATIONS WERE LISTED IN THE REPORT AS FOLLOWS: ALBUTEROL, ELIQUIS, PREDNISONE, AND TRELEGY; HOWEVER, IT IS NOT CONFIRMED IF ANY OF THESE WERE GIVEN TO TREAT HIS REPORTED SYMPTOMS AT THE TIME OF THE ALLEGED EVENT OR WERE MEDICATIONS HE TAKES REGULARLY. THE HCW¿S MEDICAL HISTORY IS NOT KNOWN, INCLUDING ANY PRE-EXISTING RESPIRATORY CONDITIONS SUCH AS ASTHMA OR COPD. THE FAMILY MEMBER WHO REPORTED THIS EVENT ASKED TO REMAIN CONFIDENTIAL; THEREFORE, NO FOLLOW-UP CAN BE DONE. LASTLY, IT CANNOT BE CONFIRMED A SERIOUS INJURY OCCURRED RELATED TO AN ASP PRODUCT, HOWEVER, ASP HAS DECIDED TO REPORT THIS EVENT OUT OF AN ABUNDANCE OF CAUTION.