INTERLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H4, AND H6. H11: THE DEVICE AND A PHOTOGRAPH WERE RECEIVED FOR EVALUATION. THE ACTUAL DEVICE AND THE RETURNED PHOTOGRAPH WERE VISUALLY INSPECTED, AND IT WAS NOTED THAT THERE WAS A SEPARATION BETWEEN THE TUBING AND MALE LUER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED; HOWEVER, THE POSSIBLE ROOT CAUSE IS RELATED TO MISSING SOLVENT IN THE TUBE. 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.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE LUER LOCK ADAPTER OF AN INTERLINK NON-DEHP MINIVOLUME EXTENSION SET SEPARATED FROM THE TUBING. IT WAS OBSERVED THAT THE DISTAL END OF THE ¿CARDIAC FILTER TUBING¿ REMAINED ATTACHED TO THE PATIENT¿S CVD RED LUMEN WHILE THE REMAINDER OF THE TUBING HAD BROKEN OFF. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.