During incoming inspection, the distributor rejected this device, 138104, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Received twenty two 138104 in unopened original packaging.Evaluations were performed on thirteen samples using aql 1.0 c=0 sampling plan, procedure wi-qa-10-47 rev.Aa.Lot number was verified.Performed a visual inspection of the device, there were no obvious signs of a breach in the seal however, the device was encroaching into the seal.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 one out of thirteen samples.Root cause cannot be determined, however, based upon a completed review of the manufacturing process, it indicated that 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 was conducted and found a total of 22 devices for this lot number.A two-year review of complaint history revealed there has been a total of 270 complaints, regarding 8,091 devices, for this device family and failure mode.During this same time frame 8,913,998 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 0.0009.Per the instructions for use, the user is advised to inspect and test each device before each 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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