FDA definition of a complaint - Customer orders spare parts

jkc3usc

Involved In Discussions
#1
FDA definition - electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance

Key word alleges.

Class II reusable devices

If my company receives a fax order or a call for parts from a costumer with no allegation of a deficiency would you considered this a complaint?
Would the need to ask more questions to dig be required?

Or would this all depend on the risk of the part and life expectancy of the part.
 
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Ron Rompen

Trusted Information Resource
#2
perhaps I'm not clearly understanding the issue here, but what you have described sounds like a regular purchase. If there is no allegation of deficiency then I don't see how it could be considered a complaint.
 

jkc3usc

Involved In Discussions
#3
is what I am thinking as well. I don't need to assume the customer is ordering the part due to a malfunction? or problem?

Would the need to ask further questions be needed. I just see that leading to a definite complaint.
 

Sidney Vianna

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Staff member
Admin
#4
As the manufacturer of the device, I believe, you would want to know as much as possible about your product performance.

If a component has an expected MTBF of 2 years and you see customers re-ordering the part every 3 months, wouldn't you want to know if the data shows a risk? Maybe the component needs re-engineering to enhance durability.

If the case in question is a one-off, I wouldn't be overly concerned, but I would start a tracking mechanism for replacement orders and see if there are any trends that could put the product durability and reliability in question.
 

jkc3usc

Involved In Discussions
#5
Thanks and I agree MTBF should be tracked. I just wasn't sure about coding it as a complaint.

Getting a fax order PO for example 40 fuses, hoses, etc without an allegation of any deficiency. Would the need to follow up and ask more questions be something the FDA would want. Or is filling the order and not documenting as a complaint sufficient.

Sorry for all the questions

thanks
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
A parts replacement order should not be coded as a complaint, in my estimation, assuming you have NO OTHER indication of unexpected failures for these parts. If there were, I would follow up with a call to customer to ascertain exactly why they are ordering it. As customer feedback about product performance is rare, that would give your organization a chance of interacting with the customer about their perception of the product performance in the field.
 
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