MEDEX EXTENSION FILTER SETS

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE EXHIBITED A BLACK DOT IN THE WHITE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

TWO UNUSED DEVICES FROM THE SAME LOT WERE RETURNED FOR INVESTIGATION. THE DEVICES WERE VISUALLY INSPECTED AND THERE WAS NO CONTAMINATION WAS OBSERVED ON COMPONENT. DURING THE PHOTO EVALUATION, THE CUSTOMER REPORTED ISSUE WAS CONFIRMED SINCE AN EMBEDDED BLACK DOT ON COMPONENT. HOWEVER, CONDITION REPORTED WAS NOT DETECTED THROUGH THE ANALYSIS OF THE RETURNED SAMPLES. THE CAUSE FOR THIS FAILURE MODE IS RELATED TO A CONTAMINATION DURING THE MOLDING PROCESS OF THIS COMPONENT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.