FDA 483 - Becton Dickinson & Co. - April 11, 2025
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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.
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ID · 0a841f48-f79f-4343-9a6e-0930bcdefef8