NRFIT CADD ADMINISTRATION SETS - FLOW STOP

Additional Manufacturer Narrative

NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE SAMPLES RETURNED WERE TESTED USING THE HYDROSTATIC VESSEL. A LEAK WAS DETECTED FLEEING FROM THE JOINT OF THE PUMP TUBE AND "TUBE 105". THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT WAS FOUND TO BE LACK/INSUFFICIENT CYCLOHEXANONE ADHESIVE".

Description of Event or Problem

IT WAS REPORTED THAT FLUID LEAKED FROM THE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

WHILE PERFORMING A REVIEW OF SUBMITTED MDR REPORT IT WAS DISCOVERED THAT THIS FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE (B)(4) IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.