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BD BBL™ Port-A-Cul™ Transport Jar Sterile Pack

Model 221602 · BECTON, DICKINSON AND COMPANY · DI 30382902216026

JSM — Culture Media, Non-Propagating Transport · Class I · 21 CFR 866.2390

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

369132019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 12.5/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.6/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1.33/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 2.33/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.5/device2023-02: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.33/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 4/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 6/device2026-01: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 1/device010203040506070809101112040506070809101112010203040506070809111201020304060709120204050607080910110103050607080910110102030405060708091112010405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0301
2019-0401
2019-0501.5
2019-0603
2019-07012.5
2019-0801
2019-0902
2019-1001
2019-1101
2019-1202
2020-0402
2020-0501
2020-0602
2020-0702
2020-0801.6
2020-0901
2020-1001
2020-1103
2020-1201
2021-0101
2021-0201
2021-0302
2021-0401
2021-0501
2021-0601
2021-0701
2021-0801.33
2021-0901
2021-1101
2021-1201
2022-0102.33
2022-0201
2022-0301
2022-0401
2022-0602
2022-0701
2022-0902
2022-1201.5
2023-0201
2023-0401
2023-0502
2023-0603
2023-0703
2023-0801.5
2023-0901
2023-1001
2023-1101.5
2024-0101
2024-0301
2024-0501
2024-0601
2024-0701
2024-0801
2024-0901.5
2024-1001
2024-1101
2025-0102
2025-0202.33
2025-0303
2025-0401
2025-0502.5
2025-0604
2025-0701
2025-0801.67
2025-0901.5
2025-1101
2025-1206
2026-0101
2026-0403
2026-0501
This device (reports/month)Average device in JSM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BECTON, DICKINSON AND COMPANY

  • Warning Letter 2018-01-11 Becton Dickinson & Company
  • Warning Letter 2009-05-11 Becton Dickinson & Company
  • NAI 2026-04-16 Becton Dickinson and Co. · 0 citations
  • NAI 2026-04-16 Becton Dickinson and Co. · 0 citations
  • NAI 2025-08-01 Becton Dickinson & Co. · 0 citations
  • NAI 2024-05-21 Becton Dickinson Infusion Therapy Systems, Inc. · 0 citations
  • VAI 2024-05-02 BECTON, DICKINSON AND CO. · 3 citations
  • VAI 2024-05-02 BECTON, DICKINSON AND CO. · 3 citations
  • NAI 2024-02-29 Becton Dickinson Industrias Cirurgicas, LTDA. · 0 citations
  • NAI 2023-09-15 Becton Dickinson and Company · 0 citations
  • NAI 2023-09-15 Becton, DIckinson and Company · 0 citations
  • NAI 2023-09-15 Becton, DIckinson and Company · 0 citations
  • NAI 2023-09-15 Becton Dickinson and Company · 0 citations
  • VAI 2023-08-02 BD Medical · 0 citations
  • NAI 2023-03-23 Becton, Dickinson and Company · 0 citations
  • NAI 2023-03-23 Becton, Dickinson and Company · 0 citations
  • NAI 2023-01-11 Becton Dickinson and Co. · 0 citations
  • NAI 2023-01-11 Becton Dickinson and Co. · 0 citations
  • NAI 2022-12-15 Becton Dickinson Industrias Cirurgicas, LTDA. · 0 citations
  • VAI 2021-11-23 BD Puerto Rico LLC · 0 citations
  • NAI 2021-07-29 Becton Dickinson Caribe LTD · 0 citations
  • VAI 2021-07-23 Becton Dickinson & Co. · 1 citations