As the lot number for the device was not provided, a review of the device history records 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 post catheter placement procedure, the patient allegedly experienced bleeding and itching.It was further reported that a tegaderm with 2 % chlorhexidine was put over the catheter site.Reportedly, additional intervention performed.The current status of the patient is unknown.
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