CURITY EYE PD 1-5/8X2-5/8 OVAL STRL
Received Feb 7, 2017
Report 1018120-2017-00022 · MDR key 6308876
Device
Product problems
- Unsealed Device Packaging
- Device Damaged Prior to Use
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. A VISUAL OBSERVATION WAS MADE AND THE REPORTED ISSUE WAS DISCOVERED. PRODUCT WAS FOUND IN THE SEAL OF THE PAPER PREVENTING THE SEALING UNIT FROM SEALING THE PACKAGE CORRECTLY. CORRECTIVE ACTIONS/PREVENTATIVE ACTIONS ARE NOT REQUIRED DUE TO THE VERY LOW TREND AND THIS HAPPENING OVER 3 YEARS AGO NO FORMAL OR CORRECTIVE ACTION PUT IN PLACE AT THIS TIME. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.
Description of Event or Problem
THE CUSTOMER REPORTED THE ISSUE: PRIOR TO USE ON A PATIENT, PACKAGE WAS FOUND OPEN. NO PATIENT INVOLVEMENT.