COMPLAINT HANDLING PROCESS DEFINITION OF A COMPLAINT Any

COMPLAINT HANDLING PROCESS

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.

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.

COMMUNICATING A COMPLAINT TO CLEARFLOW • Whom to communicate with: Ø Any Clear. Flow employee and / or representative • Means of communication: Ø Phone Ø Email Ø Fax Ø Letter Ø Product return, or Return Material Authorization • Documentation: Ø FM 003 -01, Rev D- Complaint Contact Information Form Ø Form WI 003, Rev B- Work Instruction for info to collect Clear. Flow Quality Assurance contact information: Dov Gal; p: 714. 916. 5010; email: dgal@clearflow. com

PROCESSING A COMPLAINT • The Reporter shall communicate with any Clear. Flow employee and / or representative as soon as becoming aware • Reporter and Clear. Flow 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 Clear. Flow contract manufacturer. • Reporter contacts QA for shipment instructions.