CURITY EYE PD 1-5/8X2-5/8 OVAL STRL
Received Feb 7, 2017 · Event occurred Nov 9, 2012
Report 1018120-2017-00019 · MDR key 6308708
Device
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 2/7/17. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT # 01796100 PRODUCED ON EYEPAD. THERE WERE NO MANUFACTURING RELATED ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT AND THE PRODUCT WAS RELEASE ACCOMPLISHING ALL QUALITY STANDARDS. EYEPAD IS A SLOW, MANUAL OPERATION WITH NO CTQ SENSORS. THE DIE CUTTER AND PRESS MUST HAVE JAMMED CAUSING MULTIPLE PADS TO ENTER INTO THE PAD. THE OPERATOR NEED NOT CULL ALL DEFECTIVE PRODUCTS. THIS COMPLAINT WILL BE SHARED WITH THE ASSOCIATES TO HEIGHTEN THEIR AWARENESS TO THIS DEFECT. NO CHANGES TO THE QUALITY CONTROL SAMPLING PLANS ARE DEEMED NECESSARY. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. SINCE NO COMPLAINT TREND EXISTS, NO FORMAL CORRECTIVE ACTION/PREVENTIVE ACTION HAS BEEN CREATED FOR THIS COMPLAINT. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A EYE GAUZE PAD. CUSTOMER STATES: PRIOR TO USE ON A PATIENT, THE PACKAGES WERE FOUND ALREADY OPENED. NO PATIENT INVOLVEMENT.