ARGYLE

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THE ITEM PRESENTED MEMORY AND EXTRAVASATION.

Additional Manufacturer Narrative

A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT: 2318100195 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 DEVICES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE ARE UNABLE TO ASSOCIATE THIS REPORTED ISSUE WITH AN OPEN CAPA DUE TO NO PHOTO OR SAMPLE RECEIVED FOR EVALUATION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2318100195 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS RECEIVED FOR EVALUATION AND REPORTED CONDITION OF LEAKING WAS NOT OBSERVED; HOWEVER, THE REPORTED CONDITION OF MEMORY ISSUE WAS OBSERVED. CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.