I would say - not reportable to the FDA but definitely needs to be documented with an occurrence and the steps reviewed for opportunities to improve the process. Not reportable to the FDA because the unit was designated and acceptable for transfusion to the patient. I assume the review process of inspecting the unit, documenting when it was issued, when the TX was started, any adverse events associated with transfusions, completion of the TX within the required time limit, etc was correct and documented. If the incorrect selection of unit 2 instead of unit 1 in the computer led to issuing an unsuitable unit, definitely reportable to the FDA or your State agency if they assume that role. The same thing happens frequently when a unit is issued but not saved in the computer (the saved button is not clicked) so it is not issued but stays allocated, to be corrected when the transfusion documents are accounted.