FDA Reportable Events

[Christiane 2]

Is anyone here well versed in FDA Reportable Events?

We recently had an incident whereby a unit of FFP was issued to a patient as Component B but the computer had the wrong product (component) code, so it had Component A as the issued unit.  This was one of two units of plasma which were from the same donor.  We were able to fix it in the computer shortly after the plasma was issued.  No harm to the patient anyway but still we are wondering if we have to report this to the FDA.  AABB technical Manual (19th edition) p.83-84 discusses the issue of blood product that was discovered to be in violation of the rules and a possible safety hazard for the recipient.  In this case it was the correct product with a different component code in our computer. Any thoughts on this?  We are still within the 45 days window to report a Blood Product Deviation. 

[pinktoptube 47]

I believe it would need to be reported. The unit was issued with an error. It also doesn't hurt to just submit it since the FDA will let you know if it didn't need to be reported. 

Edited January 11, 2018 by pinktoptube

[R1R2 304]

agree with pinktoptube

[QAZ 15]

When in doubt, you can ask them at BP_Deviations@fda.hhs.gov. They're very helpful and usually respond the same day.

[Christiane 2]

Thank you all for your input. I appreciate the link to fda deviations. 

[Cliff 435]

It's mislabeled, so yes, it's reportable.

We are pretty big, and send in a lot of reports.  The FDA is really easy to work with.  I've had a couple of phone calls (they called me) and many emails regarding our reports.  Again, always helpful.

[Gnapplec 15]

Yes. Even from the blood center side if we distribute a mislabeled product (isn’t even issued to a patient yet) these are definitely FDA reportable errors.  

Edited January 19, 2018 by Gnapplec