Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Need your advice ,

There was reporting and recall carried out under 1003 and 1004 to the FDA 10 years ago. The field correction was  carried out for other markets too - Australia , EU , Canada however it was considered that the risk was acceptable ( remote probability) and the event was not reported to these countries. Now after 10 years , the same complaint has occurred in Australia , the unit was part of the field correction (was inspected as part of the advisory notice, but the correction remained pending because the consignee did not respond). The hazard severity is such that it requires medical intervention so it should have been reportable even then. Now this old unit has been brought back to the facility and has been decommissioned .
What should be the correct approach to deal with this scenario now. For the FDA , I assume we have done everything , and we don't need to do anything now. But I am just confused now what needs to be done for the complaint assessment when it comes to other markets , you cant say its not reportable and then does it mean we need to check the distribution and recall the units which are not corrected on the field ?

I don't understand the extent of the field action OUS/Aus. Looks like users were sent advisory notices (you mention they did not respond..) and if the severity was high, why did you conclude the risk was acceptable? From what you say, it seems like you should have proceeded with the recall in Australia 10 y ago.
Did you determine depth of recall for Australia - this determines the effectiveness of recalls and is based on risk of device defect. If your procedures dictated a higher recall level, it is possible that the recall would have still been effective even though the user did not respond, because not all recalls can have 100% effectiveness. Some more info on all the steps you took with TGA would help you get a well-thought out  answer- was TGA involved at all? did they review your recall strategy and effectiveness checks? Did you health risk evaluation result in affected products OUS?

This thread is along similar lines and you may find it useful
https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=baa1b5f8-ed56-4228-b925-f8aa5fdcdf46&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer&ReturnUrl=%2fcommunities%2fcommunity-home%2fdigestviewer%3fcommunitykey%3d5af348a7-851e-4594-b467-d4d0983b6d89%26tab%3ddigestviewer


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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 08-Jul-2018 08:03
From: Anonymous Member
Subject: Non-reporting of recall

This message was posted by a user wishing to remain anonymous

​Need your advice ,

There was reporting and recall carried out under 1003 and 1004 to the FDA 10 years ago. The field correction was  carried out for other markets too - Australia , EU , Canada however it was considered that the risk was acceptable ( remote probability) and the event was not reported to these countries. Now after 10 years , the same complaint has occurred in Australia , the unit was part of the field correction (was inspected as part of the advisory notice, but the correction remained pending because the consignee did not respond). The hazard severity is such that it requires medical intervention so it should have been reportable even then. Now this old unit has been brought back to the facility and has been decommissioned .
What should be the correct approach to deal with this scenario now. For the FDA , I assume we have done everything , and we don't need to do anything now. But I am just confused now what needs to be done for the complaint assessment when it comes to other markets , you cant say its not reportable and then does it mean we need to check the distribution and recall the units which are not corrected on the field ?