INTERLINK

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET WAS LEAKING FROM THE FILTER. THE LEAK FROM THE FILTER WAS OBSERVED WHILE FLUSHING THE SET WITH NORMAL SALINE AFTER THE PATIENT HAD RECEIVED AN ELECTROLYTE REPLETION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6 (REPLACE B17 WITH B01, C20 WITH C19, D15 WITH D14), H11. CORRECTION: D4 EXPIRATION DATE (UPDATE TO N/A) AND D4 UDI #. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. PRESSURE TEST WAS PERFORMED AND NO LEAK WAS OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.