Evaluation summary:post market vigilance (pmv) led an evaluation five devices opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.Each circular seal was damaged.Each unit failed an air leak test due to the observed damage to the seal.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the cut circular seal.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.(b)(4).
|