{
  "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": "2026-07-07",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "event_location": "HOSPITAL",
      "report_to_fda": "Y",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20191113",
      "reprocessed_and_reused_flag": "I",
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      "report_date": "20200324",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
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      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "463524",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "PORT ACCESS NEEDLE",
          "generic_name": "SET, ADMINISTRATION, INTRAVASCULAR",
          "manufacturer_d_name": "BARD ACCESS SYSTEMS, INC.",
          "manufacturer_d_address_1": "605 NORTH 5600 WEST",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SALT LAKE CITY",
          "manufacturer_d_state": "UT",
          "manufacturer_d_zip_code": "84116",
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          "manufacturer_d_country": "US",
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          "model_number": "0142075",
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          "device_availability": "No answer provided",
          "device_report_product_code": "FPA",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Set, Administration, Intravascular",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.5440",
            "device_class": "2"
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        }
      ],
      "product_problems": [
        "Break",
        "Detachment of Device or Device Component"
      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250801",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200427",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "365 DA",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
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      "date_report": "20200324",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20200427",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000360",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20200324",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "189004630",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PT HAD PORT ACCESSED DAY BEFORE. FAMILY WAS EDUCATED ABOUT TRYING OTHER OPTIONS FOR PORT SECUREMENT B/C PORT HAS BROKEN MANY TIMES BEFORE AND TUBING HAS BECOME UNHOOKED. FAMILY FELT EVERYTHING WOULD BE OK AS LONG AS WE CHECKED THE CONNECTIONS FREQUENTLY. THE NEXT DAY THE BEDSIDE NURSE WAS CALLED IN B/C THE PORT TUBING HAD BROKEN. (NOT THE IV TUBING). NO CHEMO WAS RUNNING. PATIENT WAS QUICKLY DE-ACCESSED AND RE-ACCESSED AND NEW TUBING WAS HUNG. PATIENT HAS HAD MULTIPLE LINE ACCESS PROBLEMS WITH MANY ADMISSIONS. THIS IS AT LEAST THE 4TH PORT LINE BREAK AND PER PARENTS THE LINE HAS BECOME UNHOOKED FROM DIFFERENT ATTACHMENT SITES TOO."
        }
      ],
      "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": ""
    }
  ]
}