8MM 30CM HEMASHIELD PLAT WDV
Received Nov 24, 2014 · Event occurred Oct 27, 2014
Report 2242352-2014-01262 · MDR key 4307379
Device
Generic name
Vascular Graft
Manufacturer
Maquet Cardiovascular, LlcModel number
M00202175208P0Lot number
25096092
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THAT YELLOW FOREIGN MATTER WAS FOUND ATTACHED TO THE 8MM 30CM HEMASHIELD PLAT WDV WHEN THE MEDICAL STAFF OPENED THE PACKAGE. THE SURGEON CUT THE PART WHERE THE FOREIGN MATTER WAS ATTACHED OUT AND USED THE REST OF THE GRAFT FOR THE PATIENT WHO HAD ACUTE AORTIC DISSECTION AS BLOOD TRANSMISSION. THE PART WHERE THE FOREIGN MATTER WAS ATTACHED WILL BE RETURNED FOR INVESTIGATION.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. (B)(4).