(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported resistance felt with difficulty to remove and difficulty to position issues could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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