Retention of Customer Returned Product

#1
Hi. Long time creeper ;) - first time to ask a question.
Is there anywhere in the FDA CFR21 part 820 or ISO 13485 that states how long a company should keep a medical device that has been returned on the basis of a customer complaint before it is destroyed? We typically destroy returned product once the complaint has been resolved (closed) in writing (complete with customer notification) AND until recently, that has worked. Last week, we had a customer call us after 2 weeks of the complaint being closed and asked for the product back but we had destroyed it (a cord for a surgical instrument). The customer told us we had violated FDA protocol... HELP ... what protocol? :confused: Thank you.
 
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B

blewispunk

#2
I am not aware of any FDA protocol for how long to store customer returned material. Was the situation that you received a customer complaint and requested the product be returned so you could do an evaluation of it? I can see in this circumstance that the customer, who has their own obligation to report medical device issues if there is an associated adverse event, could feel that you hampered there ability to do their own FDA reporting by removing the suspect device and not returning it to them for their own investigation. However, considering you completed your own investigation and notified them that the investigation was complete I don't see that you did anything "wrong" - just may not be what this particular customer was expecting.
 
#3
Was the situation that you received a customer complaint and requested the product be returned so you could do an evaluation of it?
Yes, we asked for it back. No injury or potential injury occurred - Customer complained cord was not working (conducting electricity). Our Engineer's evaluation determined the cord was 'beyond life expectancy' - (it had been sterilized beyond the 20 times for reusable products) and could not be “fixed”. We informed the customer of the evaluation and we disposed of the cord. :bonk:
 
A

arios

#4
Usually, customers get a replacement for returned product, so in essence if you have reimbursed, given credit or otherwise replaced the product then technically the sample should no longer be considered customer property...It is now yours. It was sent back to you for analysis, and if the analysis implies destruction then why would a customer want more scrap back?

On the other hand if the device was for single use (apparently not the case of your subject product), the customer will most likely not expect anything back of a returned sample which will be pretty much a bio-hazardous waste.

You would consider keeping your samples for longer only in the case of possible expected legal action, I mean complaint samples that were involved in adverse events, MDR's, MDV's, etc. as they may serve for future investigation.

Per ISO 13485:2003 section 6.4 d, and if appropriate you need to have special arrangements to prevent contamination which could come from potentially contaminated product, that includes complaint samples, so please avoid unnecessary accumulation of samples which could compromise other products, your controlled environment or the personnel's state of health.
 
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G

gar4guv

#5
I am also not aware of any general retention requirements for returned product. Your customer may be making a reference to the "record retention" requirements in 21cfr820.180, but that is just documentation.

if someone says you are in violation of FDA protocol, they should be able to cite the specific regulation that they believe you are not adhering to. otherwise, how would they know what the requirements are?
 
D

DrM2u

#6
The customer told us we had violated FDA protocol... HELP ... what protocol? :confused: Thank you.
I'll join the others in saying that I am not aware of any such protocols either. For your (and my) curiosity, could you play dumb and ask the customer for a copy of said protocol? :confused: Maybe there is something we should be aware of :mg: or maybe your customer is making up things about FDA requirements (won't be the first time :mad:). Either way, please keep us posted. :bigwave:
 
A

arios

#7
Hi TurtleD

Is there any chance that your customer could be referring to a FDA protocol for their own use as Health Care Provider?
 
#8
So: the customer wanted the product back because they could "fix it" .. I am glad we destroyed it... Anyway - it appears the 'protocol' WAS record retention and not complaint product retention ... THANK YOU all for your help!!!!
 
A

arios

#10
I am also glad you resolved successfully this situation. :agree:

You may want to establish some agreements with your client should the issue recur.
 
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