EXTENSION SET

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A MICRO-VOLUME EXTENSION SET WITH 0.2 M FILTER LEAKED 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 WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H4, H6, AND H11. H11: THE DEVICE AND A VIDEO OF THE SAMPLE WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION ON THE ACTUAL SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. PRESSURE AND CLEAR PASSAGE TESTING WERE PERFORMED ON THE ACTUAL SAMPLE, AND NO SIGNS OF A LEAK OR BLOCKAGE WERE OBSERVED FROM THE DEVICE. BASED ON THE VIDEO EVIDENCE, THE REPORTED CONDITION WAS CONSIDERED VERIFIED. THE REPORTED CONDITION WAS VERIFIED IN THE VIDEO SAMPLE. THE CUSTOMER REPORTED OCCASIONAL USE OF SYRINGES SMALLER THAN 10 ML. THE CAUSE COULD NOT BE DETERMINED; HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE CONDITION WAS DETERMINED TO BE RELATED TO USE CONDITIONS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.