Guidance for Handling Complaints

How to Triage Customer Complaint Information

Part 1: Concepts and Definitions

help_center What Exactly is a Complaint?

ISO & FDA Definition

Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, effectiveness, or performance of a device after it is released for distribution.

Feedback vs. Complaint

All complaints are feedback, but NOT all feedback is a complaint. The following are not typically considered complaints:

Product information inquiries
Preventive maintenance service calls
Cosmetic defects & Shipping errors

category Complaint Categories

Adverse Event
Patient-related. Highest Priority.
Quality Issues
Not patient-related.
OBF (Out of Box Failures)
Not patient-related.
Commercial Products (FMD)
Non-Medical Devices.

Time-Sensitive Events

Patient-related events, including serious injury, death, or medical intervention, are time-sensitive and must be reported immediately upon awareness.

forward_to_inbox Complaint Reporting Contacts

Adverse Events (Any patient-related event)
To: Leonardo Aldarondo
cc: Dan Bennett
Quality Issues (Not patient-related)
To: Rusty Kelly
cc: Leonardo Aldarondo
OBF (Out of Box Failures)
To: Simone Henrys-Paul / Customer Service
cc: Leonardo Aldarondo
Non-Medical Device / Commercial Products (FMD)
To: Simone Henrys-Paul / Customer Service
cc: Leonardo Aldarondo

Why CC Regulatory on All Events?

All of the above are forms of complaints and must be logged to ensure regulatory compliance and proper tracking.

Part 2: Practical Application & Data Gathering

rule Capturing Critical Information

The Core Five Questions

Where? Identify the customer or facility.
Who? Identify who is reporting the event, who you spoke to.
What? Detail the specific issue that occurred with the product.
When? Pinpoint the exact date and time the event took place.
How? Describe the sequence of events that led to the complaint.

Key Information to Gather

Name of the Customer
Contact Person (Name, phone, email)
Serial Numbers (Device and IV Set)
Channels Involved?
Date of the Event
Patient Involved? & Drug Infused?

quiz Key Probing Questions

Go beyond the initial report to fully understand the scope and severity of the event.

Patient/User Involvement

"Did the event involve a patient or user?"
"Did the event impact a patient or user?"
If so, what was the actual impact?
What was the potential impact?

Impact on Treatment

"Did the event cause a delay in treatment or therapy?"
"Did the event cause an over-infusion?"

warning Example: Adverse Event Data Gathering

Scenario: A nurse calls to report an over-infusion that harmed a patient.

Initial Information Gathered

Customer: St. Jude's Medical Center
Contact (Who?): Susan Clark (RN), 555-123-4567
Date of Event (When?): 2025-08-15, ~2:30 PM
Product/SN: Infusion Pump (SN: X-987654), IV Set (Lot: 202501-ABC)
Issue (What?): Pump was programmed to deliver 250 mL of Fentanyl over 8 hours, but nurse noticed the bag was empty 30 minutes later.
Sequence (How?): Nurse programmed pump, returned later to find bag empty and patient in respiratory distress.