INTERLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED TO THE SAMPLES USING NAKED EYE AND NO DEFECT WAS OBSERVED. PRESSURE TEST AND CLEAR PASSAGE UNDER WATER WERE PERFORMED, AND THE RESULTS WERE SATISFACTORY, NO DEFECTS WERE OBSERVED. THE REPORTED CONDITION WAS NOT VERIFIED IN THE COMPANION SAMPLES. 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

E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

PRODUCT WAS REPORTED A Y-TYPE BLOOD/SOLUTION SET (WITH LARGE STANDARD BLOOD FILTER AND PRESSURE PUMP) LEAKED BLOOD PRODUCT FROM THE BASE OF THE PRESSURE PUMP. THIS WAS OBSERVED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.