SOL-MILLENNIUM

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED ON 01/13/2025. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT PARTS OF RUBBER MEMBRANE WAS DISCOVERED IN THE SYRINGE WHEN THEY HAD RETRIEVED THE LIQUID FROM THE GLASS BOTTLE. THE CUSTOMER SAY THAT THIS HAPPENED A LOT LATELY, BUT THEY DO NOT KNOW HOW MANY TIMES AND THEY DO NOT HAVE LOT NUMBER. ISSUE WAS IDENTIFIED PRIOR TO USE AND NO HARM REPORTED.

Additional Manufacturer Narrative

THIS REPORT WHEN INITIALLY SUBMITTED ENCOUNTERED AN INTERNAL ISSUE POTENTIALLY RELATED TO DATABASE CONNECTIVITY. THIS ISSUE WAS IDENTIFIED WHILE IMPLEMENTING CAPA-57 WHICH WAS OPENED FOLLOWING AN FDA INSPECTION. OUR EVALUATION OF THE RISK, WHICH FOLLOWS GUIDANCE FROM ISO 14971, INDICATES THAT THE OVERALL RISK FOR THE REPORTED FAILURE IS LOW. THIS EVALUATION IS BASED ON OUR TRACK AND TREND ANALYSIS AND RISK MANAGEMENT FILES WHICH ARE EVALUATED AND UPDATED CONSTANTLY BASED ON POST MARKET SURVEILLANCE. DUE TO UNAVAILABILITY OF BATCH NUMBER, THE INVESTIGATION COULDN'T BE ABLE TO CONCLUDE. AS PART OF OUR CONTINUED COMMITMENT TO OUR CUSTOMERS, SOL MILLENNIUM WILL CONTINUE TO MONITOR THE COMPLAINTS TREND FOR THE REPORTED FAILURE MODE AND TAKE ANY CORRECTIVE ACTION BASED ON OUR PROCEDURES, IF A SIGNIFICANT PATTERN EMERGES.