My company hired a consultant to do our annual audit.
The reason was due to personality conflicts in the past the President and I decided to hire a consultant.
I also liked the idea as the entire Quality program is my responsibility and this is my first position in an FDA regulated company.
We manufacture a class 1 device (wheelchair). And the Quality system when I started was a complete mess, nothing had been updated since 1999 and what was written wasn’t being followed.

My question is from a statement the Auditor made about complaint handling.
I set up our complaint program that every returned chair or request for parts is considered a complaint.
I did this because the first Company contact for a return or a replacement part is usually a customer service/sales rep.
I had the following questions programmed to come up on their screen for the above conditions.

Remember to enter:·1. Who did you speak to? ·
2. What is the specific problem?(detailed description of product or part failure) ·
3. When?( date failure occurred) ·
4. Where did it happen? ·
5. How? (Event that caused the problem) ·
6. Other Info ·
7. Ship back to? ·
8. Conclusion of the call

He said that we had to ask each time someone requests a replacement part for a repair or a unit returned for repair
And I quote” Was anyone injured or killed”. As part of the investigation into the failure that occurred.

I find this to be a little over the top and possibly asking to get sued.

We have had a few injuries and they have always been reported to us, we didn’t have to ask. Regardless to what extent do we have to investigate each occurrence as related to someone being injured or killed, when only a repair or replacement part is requested?

This would be separate from any failure Analysis of a defective part.

Thanks

I am no expert in the FDA regulations, but if you are not aware, you should point your browser to http://www.fda.gov/cdrh/manual/mdrman.html and http://www.fda.gov/cdrh/manual/mdrman.html#when&Since you are required to report failures to the FDA and timeliness for the reporting depends on possible injuries to users, it is probably correct to ask for that information.

Sidney, is right and the question is asked up front. In addition each complaint should be evaluated to determine if it is reportable.
We use something like:

Thanks for the info.
I have read the info at the FDA link and I also have a copy of a similar decision document. Some of the info I listed below.

At present our C/S reps have been trained to collect the information as listed in my original post and also to elevate any complaint to their Supervisor, myself or any of three different people in management if an injury is reported.

I guess as with most things they are open for some interpretation :argue: such as reviewed, evaluated, and investigated. I assume that any of these terms could mean that if you didn’t ask the user or dealer if there was an injury, when they requests to have a repair performed on their unit, you would not meet the requirements of the MDR, becomes aware definition.
This will take some work, as more often than not the dealers don’t even ask how a part broke. I think most of it is because we have a lifetime warranty on our product. They just assume if they don’t say anything we will fix it for free.

Now I just need terminology that C/S can use, that upper management will approve (as they are always paranoid of lawsuits) and still meet the MDR requirements. Should be no problem. :bonk:

Best regards
DG


A report is required when a manufacturer becomes aware (see definition) of information that reasonably suggests that one of their marketed devices has or may have caused or contributed to a death, serious injury, or has malfunctioned and that the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.


Sec. 820.198 Complaint files.

(3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 or 804 of this chapter, Medical Device Reporting.
(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.
(c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another
investigation is not necessary.
(d) Any complaint that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or
otherwise clearly identified. In addition to the information required by Sec. 820.198(e), records of investigation under this paragraph shall include a determination of:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis; and
(3) The relationship, if any, of the device to the reported incident or adverse event.
(e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.

Our initial contact person asks the question like:

"Was there any patient or staff involvement?" If the answer is yes it is passed on to the approiate people. The follow up people get to assess the seriousness of the event and no one gets excited with the intial question.

Partially, because the initial contact people are not trained for the fact finding and also at times the information provided falls under HIPPA.

Thanks,
I was discussing this with a few co-workers and that type of statement is what we thought would be best.
I will add yours to the mix and see what we can come up with.

Thanks Again
Don