As the lot number for the device was not provided, a manufacturing review could not be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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It was reported that some time post chronic catheter placement in the left chest, the patient allegedly experienced redness, swelling and fever.Therefore, the patient was hospitalized and blood culture test was performed which identified infection.Reportedly, the device was removed and another device was placed.However, there was no reported device malfunction.The patient was reported as stable post chronic catheter replacement.
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