ARGYLE

Additional Manufacturer Narrative

A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT 2430300086 AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO DEVICE(S) RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE; HOWEVER, BASED ON PREVIOUS EVENTS REPORTED RELATED TO THE ISSUE ¿CANNOT CONNECT TO HUB¿, CAPA QE-001381 WAS OPENED TO ADDRESS THE REPORTED ISSUE THROUGH A MORE ROBUST INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED DEFECTIVE CONNECTOR. THERE WAS NO PATIENT INJURY.