During incoming inspection, the distributor rejected this device, 138114a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Performed a functional inspection, the devices were dye leak tested which indicated that the packaging had an insufficient heat seal.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Received three 138114a in unopened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection, the devices were dye leak tested per tm-10-217 rev.F which indicated that the packaging had an insufficient heat seal on two out of the three packages.Root cause cannot be determined, however, a possible cause of this event could be due to a worn-out belt.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 288 complaints, regarding 8,508 devices, for this device family and failure mode.During this same time frame 8,641,702 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised to inspect and test each device before use.Sterility guaranteed unless package has been opened, broken or damaged.We will continue to monitor for trends through the complaint system to assure patient safety.
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