CLEARLINK

Additional Manufacturer Narrative

THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. HOWEVER, THE DEVICE WAS DISCARDED DUE TO THE LEVEL OF CONTAMINATION. NO FURTHER TESTING COULD BE PERFORMED. THE REPORTED CONDITION COULD NOT BE REFUTED OR CONFIRMED. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE TUBING SPIKE OF A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET BROKE OFF WHILE CHANGING TO A NEW BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.