Where is this taken from? I can accept this as an "ideal world" description, but I wouldn't describe it as a requirement or even a reasonable expectation. If a phone call, for example, accidentally lands in the warehouse and the warehouse/shift manager is unavailable I wouldn't expect pick&pack staff to receive or record anything. Would be nice if they did, but...
In my opinion there is some (minimal) responsibility on the complainant to pass the complaint through, such as making sure they speak to someone minimally qualified or that their contact details are recorded with a request to come back to them.
Ask yourself, if you called into your vehicle's workshop to enquire about some mechanical problem, and the cleaner picked up the phone, what would you do?...
The difference between calling in about your vehicle and calling in about a medical device malfunction is that if my vehicle is malfunctioning, that presumably doesn't affect my ability to think straight
but a medical device malfunction conceivably could.
I don't remember exactly
where I heard the detailed hypothetical scenario about the janitor picking up the phone at 3 AM and hearing someone at the other end mumble something about a device malfunction other than it being a training seminar or possibly a monthly meeting. What I do remember is the explanation to the effect that if a patient relies on the device to maintain their health, a malfunction may put them in a compromised mental state, so the manufacturer may have to meet them far more than haflway. I know, I know, they'd be more likely to call their doctor first, or even 911 if something were seriously wrong. But it is conceivable that someone in a fog could dial a wrong number or be transferred to a wrong number (think of those "Please listen carefully, as our menu options have changed" :mg: systems).
I think that the broad interpretation comes from the
Guidance Document which says:
"
2.3 When do I "become aware" that an MDR reportable event has occurred?
[FONT=Times New Roman,Times New Roman]
[FONT=Times New Roman,Times New Roman]As a manufacturer, you are considered to have "become aware" of an event whenever [21 CFR 803.3]:
• Any of your employees becomes aware of information that reasonably suggests that an event is required to be reported in a 30-day report or in a 5-day report that we have requested from you; or
...[/FONT][/FONT]"
From the regs
from 21 CFR 803.3 (b)"(2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had requested reports in accordance with 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse events, becomes aware, from any information, including any trend analysis, that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. "
CFR - Code of Federal Regulations Title 21
Now "
any of your employees" is pretty broad, right?