Initiator*

Date/Time*

Phone*

Submission Type*

Discovery Date*

Discovered By*

Department of Occurrence*

Fully describe the deviation and/or reason for CR. (What is the deviation/CR? Where did the deviation/CR take place? In what process did this deviation/CR occur? What product or customer is impacted? What form or equipment is involved or impacted? How much was affected? What was the consequence of the deviation?*

Please enter unit number(s) or Patient/Donor ID as applicable. If more than one unit number is implicated, separate each DIN by comma or press Enter.*

What are the pertinent date(s) of occurrence? For example: processing date(s), collection date(s), incident date, return date, etc.*

How did you discover this information? For example: during donation process, during manufacturing process, during record review, during an external audit or assessment, reported by donor, reported by customer, etc.*

What actions did you take? For example: Adverse Event report, donor deferred, NFT label, quarantine of products/samples, Component Retrieval, etc.*

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Please scan all pertinent evidence and documentation, and email to DonorCareNon-ProdWest@vitalant.org (Donor Care deviations) or ManufacturingProcessManagementEX@vitalant.org (deviations NOT associated with DonorCare). Please be sure to reference your name and the assigned Deviation number below.

Submission Number 1015 - 2018