NRFIT

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE FILLING A CASSETTE A LEAK WAS NOTICED. IT APPEARS THERE WAS A LEAK IN THE HOSE AT THE POINT WHERE IT JOINS THE CONNECTOR. THE INCIDENT TOOK PLACE IN THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT AND NO MEDICAL INTERVENTION REQUIRED.

Additional Manufacturer Narrative

ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION IN USED CONDITION. LOT HISTORY REVIEW FOUND THERE IS NOT A NON-CONFORMANCE OR DEVIATION RELATED TO THE FAILURE REPORTED IN THE DEVICE HISTORY RECORD FOR FINISH GOOD AND COMPONENT ASSOCIATED. ONE PICTURE WAS ATTACHED TO THE COMPLAINT. IN THE PICTURE, A LEAK BETWEEN THE LUER AND THE TUBE CONNECTION IS DETECTED, AT THE SAME TIME IN THE SAME PICTURE A BROKEN LUER IS DETECTED TOO.: DUE TO THE CONDITIONS OF THE SAMPLE RECEIVED, THE FUNCTIONAL TESTING COULD NOT BE PERFORMED, THE TUBE WAS CUT AND THE LUER WAS BROKEN, THEREFORE THE FAILURE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. ACCORDING TO SAMPLE RECEIVED, THE FAILURE MODE ¿LEAKING¿ WAS NOT CONFIRMED IN THE DEVICE RECEIVED.