{
  "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": {
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      "manufacturer_contact_zip_ext": "",
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          "manufacturer_d_address_1": "605 N. 5600 W.",
          "manufacturer_d_address_2": "",
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          "manufacturer_d_state": "UT",
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          "udi_public": "",
          "openfda": {
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      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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        }
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20200427",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000318",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20200417",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
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      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "N",
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      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "189050703",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "WHILE IN THE PROCESS OF PLACING A TRIPLE LUMEN PICC, THE GUIDEWIRE DID NOT THREAD THROUGH THE PERCUTANEOUS NEEDLE SUPPLIED IN THE KIT. PT NEEDED TO BE STUCK A SECOND TIME TO ACCESS THE VEIN USING ANOTHER IV 20G B-BRAUN ALSO SUPPLIED IN THE KIT. THE MANUFACTURER WAS NOTIFIED OF THIS EVENT. STAFF ATTEMPTED TO RETURN THE DEVICE TO THE MANUFACTURER, BUT WERE ADVISED BY BARD BD TO DISCARD AS THEY ARE NOT TAKING ANY COVID CONTAMINATED PRODUCTS. THERE HAVE BEEN TWO EVENTS WITH THIS DEVICE AT THIS FACILITY WITHIN ONE WEEK."
        }
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      "distributor_name": "",
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}