INTERLINK

Description of Event or Problem

IT WAS REPORTED THAT AN INTERLINK SYSTEM MINIVOLUME EXTENSION SET LEAKED FROM THE AIR FILTER TUBING. THIS WAS OBSERVED PRIOR TO USE FOR A METHYLENE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9. H3, H4 AND H6. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED WHICH INCLUDED PRESSURE TESTING, AND NO LEAK WAS OBSERVED IN THE AIR VENT OF THE FILTER. THE REPORTED CONDITION WAS NOT VERIFIED. 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.