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comment_72074

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. 

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  • pinktoptube
    pinktoptube

    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. 

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

  • agree with pinktoptube

comment_72075

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 by pinktoptube

comment_72083

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

comment_72089

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.

comment_72206

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 by Gnapplec

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