CADD MEDICATION CASSETTE RESERVOIR

Additional Manufacturer Narrative

ONE UNIT WAS RECEIVED, AND THREE PICTURES WERE ATTACHED TO THE COMPLAINT. NO DISCREPANCIES WERE DETECTED IN THE PICTURES. THE SAMPLE CONSISTS OF ONE CASSETTE PRODUCT FROM PART NUMBER 21-7609-24, LOT NUMBER 4420476. THE SAMPLE WAS RECEIVED IN USED CONDITIONS, WITHOUT ITS ORIGINAL PACKAGING AND INSIDE IN A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED, AND NO DAMAGE WAS OBSERVED. FUNCTIONAL TESTING DETECTED A LEAK IN THE LUER AND TUBE. THE INVESTIGATION CONFIRMED THE CUSTOMER REPORTED ISSUE. THERE IS NOT NON-CONFORMANCE OR DEVIATION RELATED TO THE FAILURE REPORTED IN THE DEVICE HISTORY RECORD.

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 INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MEDICATION LEAK DURING THE MEDICATION FILLING PROCESS. THERE WAS NO PATIENT INVOLVEMENT.