FDA 483 - Becton Dickinson & Company - July 06, 2017

The FDA Form 483 details significant deficiencies in design validation, complaint handling, MDR reporting, investigation, and personnel training for a medical device manufacturer, specifically concerning K2EDTA tubes.

**Design Validation Issues:** * The firm failed to validate (b)(4) testing used to support design changes for stoppers and tubes, in lieu of clinical studies. This includes changes to K2EDTA tubes where (b)(4) testing, lacking patient blood and clinical measurements, was used to claim no impact on performance. * A process validation report for rubber stopper compounds identified batches failing (b)(4) specifications, with no further information on the impact on performance over time. * Design input requirements for stopper changes were not adequately documented, lacking defined acceptance criteria for design inputs like (b)(4) and (b)(4) as required by SOP V08-832 Rev 6.

**Complaint Handling Deficiencies:** * The "Global Complaints Management" procedure (1501-092-000-SWI) fails to identify the (b)(4) call log as a source of complaint information. * Approximately 424 inquiries from the (b)(4) call log were retrospectively deemed complaints but were not previously reviewed or evaluated for MDR reportability. * Information from May 2015 regarding K2EDTA tubes potentially suppressing lead values was not