NRFIT RESERVOIR CASSETTE

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. 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 THERE WAS A LEAK WHILE FILLING THE CASSETTE. THE LEAK WAS IN THE INNER POCKET OF THE CASSETTE. THIS MAY HAVE OCCURRED DURING MANUFACTURING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

ONE SAMPLE CASSETTE PRODUCT WAS RETURNED FOR EVALUATION. THE SAMPLE WAS RECEIVED IN USED CONDITIONS, DECONTAMINATED, WITHOUT ITS ORIGINAL PACKAGING AND INSIDE IN A PLASTIC BAG. NO PICTURES WERE ATTACHED TO THE COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED. WHILE INJECTING LIQUID INTO THE SAMPLE, A LEAK WAS DETECTED IN THE MEDICATION BAG. ACCORDING TO SAMPLE RECEIVED, THE FAILURE MODE ¿LEAKING¿ WAS CONFIRMED IN THE DEVICE RECEIVED. LOT HISTORY REVIEW FOUND NO COMPLAINTS DOCUMENT FOR THIS LOT NUMBER.