HEMASHIELD GOLD KNITTED BIFURCATED

Additional Manufacturer Narrative

(10/4245) THE INVOLVED PRODUCT WAS RECEIVED ON JANUARY 17, 2022 AND WAS VISUALLY INSPECTED BY THE QA MANAGER ON 17-JAN-2022. HIS OBSERVATIONS ARE AS FOLLOWS: "THE ANTI-HUMIDITY POCKET HAS NOT BEEN OPENED, THE PRODUCT IS INTACT. ON THE OTHER HAND: - THE LABELING OF THE EXTERNAL BOX IS IDENTICAL TO THE PATIENT SET BUT IS DIFFERENT FROM THE INTERNAL BOX. - THE PRODUCT CONTAINED IN THE BLISTER IS A STRAIGHT GRAFT WITH A DIAMETER OF 7MM AND A LENGTH OF 60CM WHEREAS THE PRODUCT REFERENCE INDICATED ON THE BOX AND THE PATIENT SET IS A BIFURCATED GRAFT 16 X 8MM. THE PRODUCT IS THEREFORE NON-COMPLIANT. THE PRODUCT IS PHYSICALLY REJECTED." A RECALL WAS INITIATED ON JANUARY 4, 2022 TO WITHDRAW TWO INVERTED PRODUCTS FROM THE MARKET. ONE MISLABELED PRODUCT IS LOCATED IN THE US (CORRESPONDING TO COMPLAINT #(B)(4)- MFG REPORT NUMBER 1640201-2021-00034). ONE MISLABELED PRODUCT IS LOCATED IN CHINA (CORRESPONDING TO THIS COMPLAINT #(B)(4) - MFG REPORT NUMBER 1640201-2021-00026).

Description of Event or Problem

COMPLAINT # (B)(4). SEE MFG REPORT NUMBER 1640201-2021-00034.

Additional Manufacturer Narrative

(B)(4). A CAPA HAS BEEN INITIATED IN ORDER TO TAKE APPROPRIATE ACTIONS.

Description of Event or Problem

CUSTOMER ORDERED PART NUMBER M002020851680 LOT:21B10 SN: (B)(4). UPON ARRIVAL, OUTSIDE PACKAGING WAS LABELED M002020851680. HOWEVER, INSIDE THE BOX WAS M002020952070 LOT:21B10 SN:(B)(4). ACCORDING TO INITIAL INFORMATION PROVIDED BY THE CUSTOMER ON SEPTEMBER 22, 2021 : "MY COLLEAGUE CONFISCATED GRAFT: M002020952070 LOT:21B10 SN: (B)(4) DUE TO AN POTENTIAL PATIENT SAFETY ISSUE. AN RN APPROACHED HIM EXPLAINING SHE IDENTIFIED GRAFT M002020952070 LOT:21B10 SN:(B)(4). INSIDE A PACKAGE LABELED FOR M002020851680 (130529) LOT:21B10 SN:1(B)(4). GRAFT: M002020952070 LOT:21B10 SN: (B)(4) IS NOT PART OF OUR PAR LEVEL AND BASED ON OUR INVENTORY MANAGEMENT SYSTEM HAS NEVER BEEN ORDERED. PRO-ACTIVE SAFETY MEASURES WERE PERFORMED BY INSPECTING ALL OTHER HEMASHIELD GRAFTS STOCKED WITHIN THE VASCULAR CORE ¿ NOTHING MORE WAS IDENTIFIED. I¿VE ATTACHED AN IMAGE OF THE PRODUCT FOR YOUR REFERENCE, PLEASE REACH OUT SHOULD YOU HAVE ANY FURTHER QUESTIONS/CONCERNS. " (B)(4).