A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.
One lot may have experienced temperature excursions during shipment.
Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.
Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.
If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.