HALYARD
Received May 21, 2019 · Event occurred Apr 23, 2019
Report 1047429-2019-00010 · MDR key 8627595
Device
Generic name
Drape
Manufacturer
La Ada De Acuna, S. De. R. L. De C. V.Model number
42216NSLot number
AC9029081
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY REF: (B)(4), CATARACT PACK THAT INCLUDES THE FOLLOWING COMPONENT: COVER, BACK TABLE 44 X 78, REF: (B)(4) MANUFACTURED BY LA ADA DE ACUNA, S. DE. R. L. DE C. V. (REGISTRATION: (B)(4)). AVID MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2019 ORIGINATED BY (B)(4), OR (B)(4), (B)(6) ALLEGING THAT THE BACK TABLE COVER WAS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND CONSEQUENTLY IN PATIENT'S EYES. THE COVER, BACK TABLE 44 X 78 PART WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER PER REF: (B)(4), MANUFACTURER LOT: AC9029081. NO PATIENT INJURY WAS REPORTED.