MalfunctionMAL
28MM 30CM HEMASHIELD PLAT WDV
Received May 2, 2014
Report 2242352-2014-00501 · MDR key 3949418
Device
Generic name
Vascular Graft
Manufacturer
Maquet Cardiovascular, LlcModel number
M00202175428P0Lot number
25073838
Product problems
- Device Packaging Compromised
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THAT THE SIZE OF THE GRAFT WAS NOT THE SAME AS ON THE OUTSIDE OF THE BOX WHICH SHOWS A 28MM 20CM HEMASHIELD PLAT WDV.
Additional Manufacturer Narrative
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).