This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.The sample returned; it consists of two unit.No sample returned for lot for one of the reported lots.The returned samples were received in the decontaminated conditions without its original packaging.The complainant returned units were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination according to procedure.It could be observed that the catheter and port or both samples were in good condition, no discrepancies affecting their functioning were detected.Functional test was performed on the samples without the catheter trapped according information for use 1, the catheter was connected to the port in order to reproduce the failure mode or find an unusual function; then was pull in order to verify if the catheter could detach easily; the sleeve was displaced to the top of the tube and compressed, the sleeve prevent catheter detach on both cases.No discrepancies were detected, the catheters kept on the port after pulling it.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No corrective actions are required.
|