This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.One (1) sample was received without its original packaging inside a ziploc bag.Visual inspection was performed at 12 under normal lighting to received unit, in order to detect any damage on the cuff.No damage could be detected on cuff.The sample was tested on leak test.The test was performed under water per procedure.During the test, it was found a leak in the inflation line.A second inspection was performed after the leak test and it was observed a hole in the inflation line.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause is that damage occurred after the device left the manufacturing site.As a preventive action production personnel was notified by area trainer as awareness of the defect reported by the customer.
|