FDA 483 - Becton Dickinson & Co. - April 11, 2025

Becton Dickinson & Co. in Sparks, MD, a medical device manufacturer, was cited for significant deficiencies in its Medical Device Reporting (MDR) and complaint handling processes. The firm failed to submit required MDRs by combining multiple customer-reported events into single records, leading to under-reporting of potential serious injuries or malfunctions. Additionally, procedures for receiving and evaluating complaints were found to be inadequate due to this practice of comingling distinct events.