It was reported a catheter from an ultrathane cope nephroureterostomy set was used for an unspecified procedure.One day after placement, the hub detached from the device.The device was then exchanged.As reported, the patient did not experience any other adverse effects due to this incident.
|
Investigation - evaluation: a review of the complaint history, drawings, manufacturing instructions, quality control instructions and documentation was conducted during the investigation.The complaint device was not returned to aid in the investigation.The complaint device catalog number and lot information were not provided to aid in the investigation.As such, there is no evidence to suggest that nonconforming device lots exist in house or in the field.A review of current documentation was conducted and it was determined that inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.As a result of the investigation and the current available information, a root cause for this failure could not be established.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.
|