Clinical Investigation to Evaluate the Haemonetics POLFA Modified Sample Needle Assembly With Vacuum Tube Holder

Eligibility Criteria:

• Study donor must be ≥ 18 years of age.
• Study donor must weigh ≥ 110 pounds.
• Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
• Study donor's hemoglobin must be ≥12.5 g/dL.
• Study donor's hematocrit must be ≥ 38%.
• Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).
• Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation.
• Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation.
• Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures.
• Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement.
• Study donors must not have experienced any of the following:

Physical trauma consistent with associated coagulopathy within the last 30 days, Surgery within the last 30 days, Known history of hypercoagulopathy (i.e., Factor V Leiden, Prothrombin G20210A, idiopathic venous thrombotic events, etc.).

• Female study donors must not be pregnant, expected to be pregnant or breastfeeding.

Exclusion Criteria - any individual not meeting the above criteria.