This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Unique identifier and 510k are unknown.No information has been provided to date.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) samples were received.Samples were received in used conditions without their original packaging.Visual inspection was performed at 12 under normal conditions of illumination in order to detect any damage on the part.During the visual inspection, a white substance was observed inside the air line from sample.Sample 1 was filled with 5 cubic centimeter (cc) of air in order to see if there was any problem with the unit.When inflating the sample 1 with air, it was required extreme force to inflate the cuff.When the cuff was inflated.It was not possible to deflate.Sample was cut with a razor in order to see if the unit was blocked.After cut, it was found a white substance inside the air line.When inflating the sample 2 with air, it was observed that part wasn?t inflated uniformly.According to the information for use (ifu) the cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff was inflated completely.After a review of the different verifications that are performed during the manufacturing process to detect inflation problems, 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.
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