Are defective returned spare parts to be considered as a complaint?


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Our medical devices need service during the lifetime, so we (as legal manufacturer) provide spare parts to our (a) customers and to (b) our service facilities (which belong to the same company group but these service sites operate their own quality systems)

In case a spare part is returned (e.g.) because of a defect - do we need to handle this case for (a) and for (b) as a complaint (per §820.198)?
What is your opinion? Thank you!

Regards, Aphel


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I think you'd be losing valuable data if you didn't. What's the rationale for not doing so?

Thanks Yodon for your response...
The discussion came up in order to reduce efforts in complaint handling. I try to find out - if there is the explicit requirement by law to handle spare part returns as complaint...


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The return should generate a customer complaint. Both MDR and FDA and other regulatory bodies require tracking and trending of these.

Thanks Ed! Can you please refer to the specific section in the laws, which require that spare parts need to same kind of treatment in complaint handling as regular medical devices... thank you! Kind regards


"You can observe a lot by just watching."
Sec. 820.3 Definitions.

(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.

Sec. 820.100 Corrective and preventive action.

(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;

Emphasis added. Product includes components.

Your risk assessment / investigation should likely try to answer questions like "What's the risk to patient if that substandard spare part had actually been used?", "How did the substandard part leave our facility in the first place?", and "Are there any other substandard parts (spares or otherwise) that have been sent to customers?"

Ed Panek

QA RA Small Med Dev Company
Super Moderator
Just an FYI, the FDA ALWAYS audits CAPA. Then they tend to look at complaints. This is usually the standard for every audit. Look at FDA database for 483's written and there are numerous findings of complaints.
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