US FDA Blood Loss Policy - Dislodged Hemodialysis Needle

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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: US FDA Blood Loss Policy

What do you mean by "blood loss"?
 
E

Ethan Loh

#3
Re: US FDA Blood Loss Policy

Hi Marc,

Here is a bit on the background: My company produce hemodialysis needle for US market. Once a while there will be some blood loss incident due to needle dislodge, patient pull the needle out, loose joint connection to the machine, tube leaking.

All these above incidents will result in blood loss. From the US FDA MDR MAUDE Database, I see some company report MDR to US FDA even as little as 50cc blood loss.

So my manager is concern about blood loss incident as we had a few incident recently. I tried searching the US FDA website for blood loss policy but there is none.

Hope you can help.:)


 
M

MIREGMGR

#4
As far as I know, there is no separate "blood loss policy", as opposed to other types of Adverse Event. If the incident would be regarded by a qualified medical professional (doctor, nurse, biomedical engineer or risk manager) as an Adverse Event, those rules apply.

The general expectation is that if you can't show via objective evidence that the incident didn't involve your product, you should report it.
 
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