SOL-CARE

Additional Manufacturer Narrative

ALL RETAINED SAMPLES AND CUSTOMER SAMPLES WERE FOUND TO BE FULLY COMPLIANT WITH PRODUCT SPECIFICATIONS. A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE AFFECTED LOT WAS PERFORMED, AND NO ABNORMALITIES WERE IDENTIFIED IN THE DOCUMENTATION. ADDITIONALLY, NO CHANGES IN RAW MATERIALS OR MANUFACTURING PROCESSES WERE NOTED. 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. 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.

Description of Event or Problem

CUSTOMER REPORTED ON THREE OCCASIONS, THE NEEDLE STARTED LEAKING DURING THE COLLECTION OF 2-3 TUBES. AFTER REMOVING THE VACUUM TUBE, THE RUBBER SAFETY COVER ON THE NEEDLE DID NOT RETRACT. AS A RESULT, THE NEEDLE REMAINED EXPOSED. THIS CREATED AN UNSAFE SITUATION BECAUSE BLOOD LEAKED FROM THE NEEDLE.