HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR

Additional Manufacturer Narrative

THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY OUR QUALITY ASSURANCE (QA) MANAGER FOR AN EVALUATION OF THE PACKAGING COMPONENTS. HIS OBSERVATIONS ARE AS FOLLOWS: ONE TAMPER-EVIDENT LABELS ON THE PRODUCT BOX IS OPENED. THERE IS A MATCH BETWEEN THE LABELING OF THE BOX, THE PATIENT LABELS AND THE GRAFT SIZER INSIDE. HOWEVER, THE PRODUCT IN THE PRIMARY PACKAGING AND ITS LABELING (MODEL # M002020952120, LOT # 25081421) DO NOT CORRESPOND TO THE EXTERNAL BOX LABELING. IN CONCLUSION, THE PRODUCT DOES NOT COMPLY WITH THE SPECIFICATIONS DUE TO A LABELING DISCREPANCY. THE GRAFT CORRESPONDING TO THE PRODUCT BOX LABELING WAS MANUFACTURED ON SEPTEMBER 2017 BY INTERVASCULAR SAS IN (B)(6), IT WAS DELIVERED TO (B)(6) MEDICAL CENTER ON JANUARY 2018. THE GRAFT IN THE PRIMARY PACKAGING THAT WAS FOUND INSIDE THE PRODUCT BOX WAS MANUFACTURED ON JULY 2013 BY MAQUET CARDIOVASCULAR LLC IN THE UNITED STATES AND WAS DELIVERED TO (B)(6) MEDICAL CENTER ON MARCH 2014. THEREFORE, IT IS ASSUMED THAT THE PACKAGING TRANSFER OCCURRED DURING STORAGE AT THE HOSPITAL. THE MOST LIKELY CAUSE OF THIS EVENT IS A PACKAGING MIX-UP DURING STORAGE AT THE HOSPITAL.

Description of Event or Problem

IT WAS REPORTED THAT THE GRAFT INSIDE THE PRODUCT BOX DID NOT MATCH THE BOX LABELING. THE PRODUCT WAS NEVER OPENED OR IMPLANTED.