CURITY EYE PD 1-5/8X2-5/8 OVAL STRL
Received Feb 7, 2017 · Event occurred Dec 8, 2011
Report 1018120-2017-00018 · MDR key 6308647
Device
Product problems
- Difficult to Open or Remove Packaging Material
- Packaging Problem
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# 91316100 PRODUCED ON MACHINE EYE PAD. THERE WERE NO MANUFACTURING RELATED ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT AND THE PRODUCT WAS RELEASE ACCOMPLISHING ALL QUALITY STANDARDS. A SAMPLE WAS RETURNED AND VISUAL INSPECTION DID CONFIRM PAD IN THE SEAL. DURING THE PROCESS OF RUNNING, THE OPERATOR DID NOT DETECT THE PAD IN THE SEAL DUE TO ONLY THE BOTTOM LAYER OF THE GAUZE WAS STRUCK IN THE SEAL. THIS COMPLAINT WILL BE SHARED WITH THE MANUFACTURING ASSOCIATES TO HEIGHTEN AWARENESS OF 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. 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) 2017 THAT A CUSTOMER HAD AN ISSUE WITH AN EYE GAUZE PAD. CUSTOMER STATES: THE GAUZE HAD BEEN SEALED WITH THE PACKAGE CAUSING NOT TO BE TAKEN OUT. NO PATIENT INVOLVEMENT.