1. COMPLAINT HANDLING PROCESS

2. DEFINITION OF A COMPLAINT Any written, electronic, or oral communication that alleges deficiencies of a distributed device related to: Identity Quality Durability Reliability Safety Effectiveness, or performance.

3. DEFINITION OF A REPORTABLE EVENT Reportable events are the adverse events or problems that the medical device regulation requires to be reported. These include: Device-related deaths Device-related serious injuries Device malfunctions that are likely to cause or contribute to a death or serious injury if they were to recur.

4. COMMUNICATING A COMPLAINT TO CLEARFLOW Whom to communicate with:  Any ClearFlow employee and / or representative Means of communication:  Phone  Email  Fax  Letter  Product return, or Return Material Authorization Documentation:  FM003-01, Rev D- Complaint Contact Information Form  Form WI003, Rev B- Work Instruction for info to collect ClearFlow Quality Assurance contact information: Dov Gal; p: 714.916.5010; email: dgal@clearflow.com

5. PROCESSING A COMPLAINT The Reporter shall communicate with any ClearFlow employee and / or representative as soon as becoming aware Reporter and ClearFlow QA communicate with each other to obtain all necessary information to determine if the complaint shall be reported Reporter coordinates shipment of the device(s) involved with the complaint back to ClearFlow contract manufacturer. Reporter contacts QA for shipment instructions.