Earlier this year we reported Covidien’s recall and withdrawal of its Duet TRS stapler line (Universal Straight and Articulating Single Use Loading Units) as a result of adverse events reportedly associated with use of the device. Now FDA has sent the company a knuckle-rapping letter (which reads like a Harry potter “Howler”) on the subject in which it claims the company failed in its duty to initiate corrective or preventive action even when furnished with trend data suggesting it had a problem.
FDA’s warning letter to Covidien was issued earlier in June and can be found here. In it the agency says the company failed to initiate a corrective and preventative action (CAPA) and despite receiving numerous complaint, adverse event, and serious adverse event information did not initiate a CAPA investigation until after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.
Covidien responded to FDA’s original concerns, but the agency apparently didn’t judge the response adequate as it failed to describe or provide evidence of implementation of a correction or corrective action. Specifically it did not retrospectively review complaints to ensure that documented corrective actions were implemented, for the complaints received for abdominal indications of use for similar patient injuries/deaths.
Then there was the matter of complaint investigation and reporting, where again FDA was less than satisfied, stating;
“your firm has received reports of deaths and serious injuries associated with the use of the DUET TRS Reload since 2009, as shown in your firm’s monthly tracking graphs. However, your firm failed to document investigations into deaths and serious injuries that resulted in issuance of a Safety Alert for use of the DUET TRS Reload in Japan in March 2011. When investigators requested documentation covering the investigations of these complaints, your firm provided interoffice emails that related to two trips to Japan taken by one of your firm’s medical officers. When the investigators inquired why these emails were the only documentation available, a letter was provided to one of the investigators explaining your firm’s reasoning, as the documentation requested was not kept in an organized state in the normal course of business.”
So what happens next?
Covidien has fifteen business days to respond, time which is just about up at the time of writing. It has to explain specifically what it’s doing to correct the noted violations, as well as an explanation of how it plans to prevent recurrence.
Quite a pasting for the company, but in itself an interesting contrast between FDA’s public airing of this type of event and the more discreet treatment it would get in Europe… for better or worse. We’ll be interested in the company’s response because FDA is sounding like it’s uncovered problems one wouldn’t expect of such an experienced and indeed sizeable outfit.