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 during apheresis treatment, when accessing the lateral port device of two in the same pocket, the fluid squirted out of the other access site.It was further reported that the health care provider allegedly did not fully seat the needle in the port septum.Reportedly, after fully seating the access needle in the port septum, the patient was able to complete treatment.There was no reported patient injury.
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