HALYARD
Received Jul 5, 2019 · Event occurred Jun 4, 2019
Report 1047429-2019-00014 · MDR key 8764654
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 INC. IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY REF: NHJV0014-07, CATARACT PACK PIGGYBACK THAT INCLUDES THE FOLLOWING COMPONENT: COVER, BACK TABLE 44 X 78, REF: 42216NS MANUFACTURED BY LA ADA DE ACUNA, S. DE. R. L. DE C. V. (REGISTRATION: 3005997949). AVID MEDICAL RECEIVED A COMPLAINT ON 06/07/19 REPORTED BY O&M HALYARD. THE COMPLAINT HOWEVER WAS ORIGINATED BY (B)(6) ALLEGING THAT THE BACK TABLE COVER IS LEAVING LOOSE FIBERS ON THE STERILE FIELD AND CONSEQUENTLY IN PATIENT'S EYES. THE COMPLAINT COMPONENT WAS NOT AVAILABLE FOR EVALUATION PER COMPLAINANT. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER FOR REF: 42216NS, MANUFACTURER LOT: AC9029081. NO PATIENT INJURY WAS REPORTED.