A user facility medwatch report (# (b)(4)) was received on 06/02/2022 reporting hole in outer blue drape, did not penetrate plastic bag.A photo of the hole in outer blue drape was provided to deroyal for evaluation.Potential root cause: it is possible that it may be the placement of the graduate pitcher handle.The placement of the graduate pitcher handle needs to be turned different inside the tray, to prevent holes in the back table cover.Corrective action: quality control specialist contacted tray engineering to evaluate the tray for a placement change on the graduate with handle.With emphasis on the way the handle is turned inside the tray to prevent holes in the back table cover.Engineering change order number (b)(4) has been created to update the routing on the graduate.Preventive action: weekly inspections are being performed by supervisors and maintenance to inspect all manufacturing surfaces for potential hazards to outer packaging.Complaint trends are being monitored to verify effectiveness of action taken.An inventory check was made by deroyal, a total of 50 back table covers were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
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