Specification Developer Fails to Submit MDR Reports

Specification developer Circulatory Technology failed to submit medical device reports within 30 days of receiving complaints that its Better Bladder device failed during use, collapsing as a result of leaks, an Aug. 22 to Sept. 26, 2018 FDA inspection revealed.

The Oyster Bay, New York, facility received five complaints that its Better Bladder device failed during use, but the firm did not investigate the failures or report the malfunction to the FDA. This was a repeat observation from a July 8, 2016 inspection, the agency said.

The FDA inspector requested documents pertaining to the leak tests and pressure tests conducted, but the firm did not provide any documentation to show that such tests were conducted.