Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).Additional information: pictures were returned.Five pictures were attached and reviewed.Pictures 2 and 3 show an uncuffed tube, pictures 1, 4, and 5 show the trach shaft unattached and held by a wire.Functional testing could not be performed as no product was returned for analysis.The pictures sent does not clearly show how the reported failure could've occurred, and no lot information was provided for device history review.The root cause could not be confirmed.
|