This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).Manufacturing device history record 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 inspection revealed the sample was in used conditions, without original packaging and with its certificate of safe handling.During functional testing, the sample was filled with 5cc of air and when the sample was inflated with air, the cuff only inflated one side.According to the ifu (instructions for use) the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times and all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.
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