CLEARLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE VISUAL INSPECTION OF THE PHOTOGRAPH REVEALED THAT IT ONLY SHOWED THE PRIMARY PACKAGING OF THE PRODUCT. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE PRODUCT CODE (01) AND LOT NUMBER (10) ARE UNKNOWN; THEREFORE, THE UDI IS NOT AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED BLOOD SET HAD DIFFICULTY TO FLOW THE BLOOD THROUGH THE TUBING. THE FLOW EVENTUALLY STARTED; HOWEVER, IT WAS DIFFICULT TO PUSH THE SPIKE TO REACH THE ACTUAL BLOOD. IT APPEARED THAT THE SPIKE WAS NOT LONG ENOUGH. THIS ISSUE OCCURRED DURING USE, BUT IT WAS UNSPECIFIED WHETHER A PATIENT WAS INVOLVED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.