What is a "Device Malfunction" for MDR purposes?

#1
I have an interesting situation with a Complaint and I'm not sure if it's reportable or not. A user engaged a consumer medical device, a single piece of molded plastic, in a normal manner but for some reason the device got stuck and required the use of forceps at an urgent care facility to remove. No injury was reported despite being in the user's body for over 24 hours.

I'm going through the reportability criteria and since there was no injury it doesn't satisfy those criteria. Looking at the device malfunction side, I could see how if this happened again it might cause serious injury due to infection given the area of use. However, the device didn't "malfunction" in the sense that it failed or broke or even didn't do what it was supposed to do. It's entirely possible the user could have put it right back in their body and not had this happen again--same piece of plastic, nothing different at all.

The FDA defines "malfunction" in 803.3 as:
(k) Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of this chapter.
The thing is here, the device did exactly what it was intended to do (it never stopped performing its intended use). Sure it's supposed to come out easily too, but there's no obvious aspect of the device that created this situation. It's basically some freak anatomical coincidence. Is this a "malfunction" of the device?

We're just the private-label distributor so I'll report it to the actual Manufacturer, but I'm curious what everyone thinks.

Thanks,
~Josh
 
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shimonv

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#2
Hi Josh,
For sure, you have to report it to the legal manufacture. The device itself did not break but it could be that its design is inherently flawed, and thereby not achieve its intended purpose. It could also be an isolated event caused by user mishandling.
The manufacture will need to review the records, consult their medical director, and take action as needed.

Shimon
 
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