HEMASHIELD PLATINUM WOVEN STRAIGHT
Received Oct 11, 2022 · Event occurred Aug 31, 2022
Report 1640201-2022-00032 · MDR key 15575941
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175126P0Catalog number
M00202175126P0
Lot number
22B02
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PRODUCT, HE FOUND THERE WERE SOME YELLOW SPOTS ON THE SURFACE OF THE GRAFT. HE CHANGE ANOTHER GRAFT INSTEAD. THE EVENT OCCURED PRIOR TO USE, THE SURGERY WAS NOT DELAYED AND NO HAZARD ISSUE OCCURRED. COMPLAINT # (B)(4).
Additional Manufacturer Narrative
(10/3233) THE INVOLVED DEVICE IS AVAILABLE AND WILL BE RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION WILL BE PERFORMED. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 22B02. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE/PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (4102/3233) A RETENTION SAMPLE FROM ANOTHER STERILIZATION LOT NUMBER 22B09 WAS SELECTED BASED ON THE SAME COATING PARAMETER AS THE INVOLVED DEVICE. A VISUAL INSPECTION WILL BE PERFORMED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Additional Manufacturer Narrative
(4102/213) A RETENTION SAMPLE FROM ANOTHER STERILIZATION LOT NUMBER 22B09 WAS SELECTED BASED ON THE SAME COATING PARAMETER AS THE INVOLVED DEVICE. A VISUAL INSPECTION WAS PERFORMED ON (B)(6) 2022 BY THE QUALITY ASSURANCE SUPERVISEUR, WHICH CONCLUDED THAT : THE PROSTHESIS IS UNIFORMLY YELLOW, NO COLLAGEN EXCESS. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
COMPLAINT # (B)(4).
Additional Manufacturer Narrative
(10/213) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR AND INSPECTED BY THE QA SUPERVISOR AND A QUALIFIED QUALITY CONTROL TECHNICIAN ON 14-DEC-2022. THEIR OBSERVATIONS ARE AS FOLLOWS: "COMPARED TO THE REPORTED VARIATION, THE PRODUCT SHOWS THE USUAL YELLOW HALOS OF COLLAGEN AFTER STERILIZATION . A MORE SHINY SPOT IS PRESENT IN ONE AREA AND CORRESPONDS TO AN EXCESS OF COLLAGEN THAT DOES NOT GO BEYOND THE CRIMPS AND IS WELL ATTACHED TO THE GREIGE AND THEREFORE DOES NOT CORRESPOND TO A CLUSTER." IN CONCLUSION, THE DEVICE IS CONFORM TO THE PRODUCT SPECIFICATIONS. (67) THE CONDUCTED INVESTIGATION CONCLUDES THAT THE PRODUCT IS CONFORM TO THE SPECIFICATION.
Description of Event or Problem
COMPLAINT #(B)(4). MFG REPORT #1640201-2022-00032.