Q: To what extent is a manufacturer responsible for filing a Medical Device Report (MDR) when a lack of training affects a patient, or when a complaint has not been sent to the manufacturer?
For example, if we found that a nurse over-infused a patient by entering an incorrect dosage — where would the responsibility for reporting that event lie?
What if, in one instance, the hospital assumed the event was the nurse’s fault and didn’t file a complaint — yet in another similar instance the hospital issued a complaint regarding the device?
A: FDA has said that an MDR may be required even if the event is associated with “use error” (FDA’s preferred term instead of “user error”).
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]It doesn’t matter how you learned of the complaint — you must still treat it as a complaint.[/pullquote]
It doesn’t matter how you learned of the complaint — you must still treat it as a complaint. If the complaint is not sent to you directly, but you learn of it via another means — perhaps it was verbally relayed to a sales or service representative — then it’s still a complaint and still may be reportable as an MDR.
You’ll want to take these steps:
First, document the event in your complaints database using all the information you have. Then determine its reportability.
Ask yourself: if the use error were to reoccur, could it cause or contribute to a death, serious injury, or serious illness?
If the answer is yes, then you — as the manufacturer — need to file an MDR.
Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA investigator and as the co-editor of FDA’s Investigation Operations Manual). Denise also is the lead instructor and developer of EduQuest’s CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations and Complaint Management training class