Additional information a device history record (dhr) review was completed for the reported lot number.There were no manufacturing related issues related to the complaint.Inspections are performed based on a statistical sampling both physically and visually.Specifically, operators are required to inspect samples at the beginning, middle and end of lots.These checks are noted on the dhr.A photo was submitted for evaluation with the complaint.From the photo it can be seen that the element has separated from the sponge.The photo shows the coloring of the radiopaque element to be a solid blue.Radiopaque elements that are produced at this manufacturing site are comprised of white and blue polyvinyl chloride, and the element will be speckled white and blue throughout.From the picture we cannot confirm the complaint.A sample was sent in; however, the sample was only the lid of a tray package.Sponges were not submitted for review, so an analysis cannot be done.Operators are being briefed on the customer¿s complaint.The root cause could not be determined.Without a physical sample to evaluate, a corrective and preventative action (capa) cannot be completed.This complaint will be used for trending purposes.
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