EXTENSION SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6, AND H11. H11: THE DEVICE AND A VIDEO OF THE SAMPLE WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED TO THE ACTUAL SAMPLE RECEIVED, AND ALL COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO THE SPECIFICATION. NO VISUAL DEFECTS WERE OBSERVED IN THIS UNIT. THE SAMPLE WAS THEN SUBMITTED TO PRESSURE TESTING, AND A LEAK WAS NOT OBSERVED. IN ADDITION, THE SAMPLE WAS SUBMITTED TO CLEAR PASSAGE TESTING, AND NO BLOCKAGE WAS DETECTED. THE RETURNED VIDEO WAS REVIEWED, AND IT WAS NOTED THAT THERE WAS A LEAK FROM THE FILTER VENT HOLE. THE REPORTED CONDITION WAS VERIFIED IN THE VIDEO SAMPLE. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A UNSPECIFIED QUANTITY OF MICRO-VOLUME EXTENSION SETS WITH 0.2 M FILTER WERE LEAKING FROM THE AIR VENTING MECHANISM. THE PROCESS STEP AT WHICH THE ISSUE OCCURRED WAS NOT SPECIFIED. IT WAS STATED THAT USERS MANUALLY PRIME THE LINES, OCCASIONALLY USING SYRINGES SMALLER THAN 10ML. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

D4 UDI: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.