H.6.Investigation: multiple photos were provided to our quality team for investigation.The pictures received displays product from lot 1905017, item 405120 and lot 1903006, item 405127 inside packages that are labeled as lot 1808018, item 405129.Based on the photo, we are able to verify the reported failure.Retained samples of each item and lot number were inspected and all product within the packages was correct.A device history review for reported lot 1808018 did not reveal any annotations or non-conformances during the manufacturing process related to this issue.All lots, 1808018, 1903006, 1905017 were manufactured and sent for sterilization during separate months, never being housed within the facility during the same time.Product undergoes visual inspections prior to release, including verifying the proper product and quantity is within each package.All inspections for these lots were completed according to procedure, no annotations were noted related to the reported incident.Based on the available information we are not able to identify a root cause related to our manufacturing process at this time.
|