{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 35
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "1119779-2021-00261",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20210208",
      "manufacturer_address_2": "",
      "pma_pmn_number": "NA",
      "date_of_event": "20210115",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "FOREIGN",
        "OTHER",
        "USER FACILITY"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "JA",
      "manufacturer_contact_area_code": "",
      "date_added": "20210208",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "195295",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20210208",
          "brand_name": "BD PLATE MCCDA CLEAR - HT",
          "generic_name": "NA",
          "manufacturer_d_name": "BECTON, DICKINSON & CO. (SPARKS)",
          "manufacturer_d_address_1": "7 LOVETON CIRCLE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SPARKS",
          "manufacturer_d_state": "MD",
          "manufacturer_d_zip_code": "21152",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "21152",
          "device_operator": "0",
          "expiration_date_of_device": "20210122",
          "model_number": "",
          "catalog_number": "252950",
          "lot_number": "0282462",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "JTN",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "1119779"
            ],
            "fei_number": [
              "1119779"
            ],
            "device_name": "Susceptibility Test Discs, Antimicrobial",
            "medical_specialty_description": "Microbiology",
            "regulation_number": "866.1620",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Incorrect, Inadequate or Imprecise Result or Readings",
        "Incorrect, Inadequate or Imprecise Result or Readings"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250806",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20210208",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210203",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11293370",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210118",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "232046809",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4). INVESTIGATION SUMMARY: THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND RETURNED SAMPLE. A CUSTOMER REPORT IS NOT REQUIRED, AND IT IS KNOWN DEFECT AND THE TREND HAS NOT SHOWN A REMARKABLE RISE, SO WE DECIDED THAT FURTHER INVESTIGATIONS IS NOT NECESSARY. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE."
        },
        {
          "mdr_text_key": "232046810",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT PRIOR TO USE WITH BD PLATE MCCDA CLEAR - HT THE PLATE WAS DISCOVERED TO BE CONTAMINATED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}