NRFIT CADD CASSETTE RESERVOIRS - FLOW STOP

Additional Manufacturer Narrative

VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED ON THREE PICTURES RECEIVED AND ONE SAMPLE RETURNED. PHOTO 2 SHOWS A CASSETTE PRODUCT AND A FEMALE LUER WITH A LEAK. THE SAMPLE CONSISTS OF ONE CASSETTE PRODUCT. SAMPLE WAS RECEIVED WITHOUT ORIGINAL PACKAGE. THE SAMPLES WERE TESTED FOR LEAK BY PASSING WATER THROUGH IT. LEAKS WERE DETECTED IN THE LUER. THE ROOT CAUSE WAS DETERMINED TO BE INADEQUATE DISPENSER USED IN THE OPERATION. A DEVICE HISTORY REVIEW (DHR) WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT WHEN FILLING UP MEDICAL FLUID INTO THE PRODUCT AT A PRE-USE CHECK, THE CUSTOMER NOTICED MEDICAL FLUID WAS LEAKING FROM THE PART WHERE THE CONNECTOR AND THE TUBING WERE CONNECTED. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: 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 CC-0095918 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.