Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period dec-2019 through nov-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device & testing of raw/starting materials: (10 & 4105/13/22) the device was returned to the factory for evaluation on 12/08/2021.An investigation was conducted on 12/14/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device but not in its normal position.It was inserted upside down and twisted sideways.The delivery device was not lined up with loading device.The white plunger on the delivery device was not depressed and the blue slide lock was not engaged.The seal was observed in the loading device window.The delivery device was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly remained in the loading device due to the improper insertion of the delivery device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.The seal was observed to be intact.No cracks or delamination was observed on the seal.Measurements were taken of the delivery tube; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.221 inches.The length of the delivery tube was measured at 2.47 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "fitting problem" was confirmed.
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