HEMASHIELD
Received Jul 10, 2020 · Event occurred Jun 8, 2020
Report 1640201-2020-00012 · MDR key 10257703
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175824P0Catalog number
M00202175824P0
Lot number
19D10
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
COMPLAINT (B)(4). SEE MFG REPORT 1640201-2020-00012.
Additional Manufacturer Narrative
THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY OUR QUALITY ASSURANCE SUPERVISOR WITH A QUALITY CONTROL TECHNICIAN. THE INSPECTION WAS PERFORMED USING A MAGNIFYING GLASS AND A BACKLIT TABLE. IT WAS OBSERVED THAT THE TINY HOLE DETECTED BY THE CUSTOMER WAS A SEWING DEFECT NOT VISIBLE FROM THE INSIDE OF THE PROSTHESIS AND THE LIGHT DID NOT PASS THROUGH. THEREFORE, THE DEFECT IS CLASSIFIED AS AN ACCEPTABLE DEFECT IN ACCORDANCE WITH OUR LIST OF STANDARDS FOR ACCEPTATION AND REJECTION OF PRODUCTS. THE PRODUCT IS COMPLIANT. (67) THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT IS NOT DEFECTIVE.
Description of Event or Problem
COMPLAINT # (B)(4). BUBBLES COMING OUT FROM THE TINY HOLE WHEN TESTED THE GRAFT. DISCOVERED BEFORE IMPLANTATION, THE GRAFT WAS NOT USED. THEY JUST PUT SOME SALINE ON THE TRAY OF THE GRAFT AND SOME BUBBLES COMING OUT FROM THE TINY HOLE.