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Performing Investigation of used returned expired devices

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Shakstang

#1
We have a next generation device on the market. Next generation device was released in August 2007. We are still receiving back used devices, which failed during a procedure and require investigations. The devices coming back have Lot Numbers (from the old generation devices) that have already surpassed the shelf life (expired). Per FDA guideline, do we as a device manufacturer still have to perform thorough investigations on those "used" expired products or can we just create a one-page letter stating that since the shelf life has expired, it will be redundant to perform a thorough investigation. In addition, the next generation device should correct the failure mode that was seen in the expired returned/used device(s).
 
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Wes Bucey

Prophet of Profit
#2
I've never heard a problem quite like this. I'll be interested in the replies we get from Covers more familiar with dealing with devices which have failed in the field.

At first blush, it might seem important to do a thorough investigation to assure you do NOT need to issue a warning or alert to end users to withdraw devices from use at the expiration date, especially depending on whether the investigation shows some age- or use-related failure endemic to all devices (new version as well as old.)
 

CarolX

Super Moderator
Super Moderator
#3
Hi Shakstang and welcome to the Cove!

I moved your thread to the FDA board - may be able to get you some responses here.
 
M

madannc

#4
Next generation device was released in August 2007. We are still receiving back used devices, which failed during a procedure and require investigations. The devices coming back have Lot Numbers (from the old generation devices) that have already surpassed the shelf life (expired).
Why is it taking so long for you to recieve the failed devices back?, there is a clause 820.198 (a) (1) ...All complaints shall be processed in a uniform and timely manner... It appears your shelf life is short therefore the mechanism/process for returns should be investigated.

Per FDA guideline, do we as a device manufacturer still have to perform thorough investigations on those "used" expired products or can we just create a one-page letter stating that since the shelf life has expired, it will be redundant to perform a thorough investigation.
820.198 (c) ...Any complaint involving the possible failure of of a device... to meet any of its specifications shall be reviewed, evaluated and investigated, unless such investigation already been performed for similar...

You have stated that the next generation "should" correct the failure mode, I would be more assertive here it either does or does not, if it does how do you know, what I am driving at is, if you were aware of the problem and have already investigated and corrected, this may cover this clause, I say may because I do not know all the details and have not seen what work was done to produce next generation... I would get your QA and RA group to look closely at this.

In answer to your your question "thorough investigation" I have one of my own

Was this a reportable event i.e. FDA part 803?

IMHO what this hinges on is the work that was done for next generation, and what you are doing to address the lateness of customer returns
 

GStough

Staff member
Super Moderator
#5
Why is it taking so long for you to recieve the failed devices back?, there is a clause 820.198 (a) (1) ...All complaints shall be processed in a uniform and timely manner... It appears your shelf life is short therefore the mechanism/process for returns should be investigated.



820.198 (c) ...Any complaint involving the possible failure of of a device... to meet any of its specifications shall be reviewed, evaluated and investigated, unless such investigation already been performed for similar...

You have stated that the next generation "should" correct the failure mode, I would be more assertive here it either does or does not, if it does how do you know, what I am driving at is, if you were aware of the problem and have already investigated and corrected, this may cover this clause, I say may because I do not know all the details and have not seen what work was done to produce next generation... I would get your QA and RA group to look closely at this.

In answer to your your question "thorough investigation" I have one of my own

Was this a reportable event i.e. FDA part 803?

IMHO what this hinges on is the work that was done for next generation, and what you are doing to address the lateness of customer returns
I would also consider 820.198(b) "Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate."
 
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