CADD EXTENSION SETS

Additional Manufacturer Narrative

B3: DAY OF EVENT IS UNKNOWN. DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED. NO DAMAGE OR OTHER DEFECTS WERE DETECTED ON THE SAMPLE. DURING THE FUNCTIONAL TESTING, A LEAK WAS DETECTED AT THE JUNCTION BETWEEN THE TUBE AND THE CONNECTOR. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE COMPLETED AS NO LOT NUMBER WAS PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT LIQUID LEAKAGE OCCURRED FROM EXTENSION TUBE DURING THE SELF-TEST. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.