The catalog number identified has not been cleared in the us, but is similar to the chrono titanium port products that are cleared in the us.The pro code for the titanium port products is identified.As the lot number for the device was provided, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
|
This report summarizes one malfunction.A review of the reported information indicated that model 0605510ce implanted ports allegedly experienced reflux within device, obstruction of flow and material deformation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
|