Becton, Dickinson & Co., (bd)

Reports per year

Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA9,436
• Needle, Hypodermic, Single LumenFMI2,418
• Set, Administration, IntravascularFPA556
• Container, Specimen, SterileFMH93
• Syringe, PistonFMF17
• Monitor, Microbial GrowthJTA7
• Culture Media, Non-Propagating TransportJSM5
• Discs, Strips And Reagents, Microorganism DifferentiationJTO4
• Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ3
• Lymphocyte Separation MediumJCF2

Recent recalls

• 2015-12-23TerminatedUnder Investigation by firm

  Vancomycin Screen Agar

  The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

• 2015-12-23TerminatedUnder Investigation by firm

  Enterococcus Screen Agar QUAD Plate

  The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

• 2015-06-18TerminatedDevice Design

  BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.

  Potential for false positive Chlamydia trachomatis (CT) results and Neisseria gonorrhoeae (GC) results when processing the CT Qx and GC Qx Assays on the BD Viper LT Instrument.

• 2015-06-10TerminatedProcess control

  BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.

  The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.

• 2015-06-10TerminatedProcess control

  BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.

  The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.

• 2015-01-14TerminatedMaterial/Component Contamination

  TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.

  A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

• 2015-01-14TerminatedMaterial/Component Contamination

  CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.

  A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

• 2015-01-14TerminatedMaterial/Component Contamination

  Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.

  A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.

• 2014-09-10TerminatedUnder Investigation by firm

  The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.

  The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.

• 2014-01-30TerminatedNonconforming Material/Component

  BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing.

  Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens.