NA

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT TWO (2) MICRO-VOLUME EXTENSION SETS LEAKED AT THE FILTER PRIOR TO THERAPY. A SYRINGE WAS USED TO PRIME THE TUBING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H4, H6 (UPDATE CODES), H11. H11: THREE (03) ACTUAL DEVICES AND TWO (02) PHOTOGRAPHS WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A PRESSURE TEST WAS PERFORMED AND A LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER IN ONE OF THE RETURNED SAMPLES. THE REPORTED CONDITION WAS VERIFIED IN ONE OF THE SAMPLES. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.