{ "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": 21943 } }, "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": "Injury", "report_number": "3006260740-2020-01518", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200428", "manufacturer_address_2": "", "pma_pmn_number": "K081311", "date_of_event": "20200323", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200428", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "468603", "implant_date_year": "2020", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200428", "brand_name": "GROSHONG PORT S/L CHINA ONLY", "generic_name": "PORT & CATHETER, IMPLANTED, INTRAVASCULAR, SUBCUATNEOUS", "manufacturer_d_name": "BARD ACCESS SYSTEMS", "manufacturer_d_address_1": "605 N. 5600 W.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SALT LAKE CITY", "manufacturer_d_state": "UT", "manufacturer_d_zip_code": "84116", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "84116", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "0603870C", "lot_number": "REDR3694", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LJT", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00801741111280", "udi_public": "(01)00801741111280", "openfda": { "device_name": "Port & Catheter, Implanted, Subcutaneous, Intravascular", "medical_specialty_description": "General Hospital", "regulation_number": "880.5965", "device_class": "2", "registration_number": [ "3006260740" ], "fei_number": [ "3006260740" ] } } ], "product_problems": [ "Disconnection", "Migration or Expulsion of Device", "Disconnection", "Migration or Expulsion of Device" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/18/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250817", "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": "20200428", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 DA", "patient_sex": "", "patient_weight": "55", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20200519", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10005297", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200331", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "317089590", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURED RELATED CAUSE FOR THIS EVENT. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. INVESTIGATION SUMMARY: A SAMPLE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. H10: D4 (EXPIRY 03/2022), G4 H11: H6 (DEVICE CODES) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD." }, { "mdr_text_key": "317089591", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THIRTEEN DAYS POST PORT PLACEMENT PROCEDURE IN THE RIGHT CHEST WALL, THE CATHETER ALLEGEDLY DISCONNECTED FROM THE PORT BODY AND MIGRATED INTO THE HEART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED BY INTERVENTIONAL MANNER. PATIENT WAS STABLE POST CATHETER REMOVAL." }, { "mdr_text_key": "189589203", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. MEDICAL DEVICE - EXPIRY 03/2022." }, { "mdr_text_key": "189589204", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT THIRTEEN DAYS POST PORT PLACEMENT PROCEDURE IN THE RIGHT CHEST WALL, THE CATHETER ALLEGEDLY DISCONNECTED FROM THE PORT BODY AND MIGRATED INTO THE HEART. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED BY INTERVENTIONAL MANNER. PATIENT WAS STABLE POST CATHETER REMOVAL." } ], "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": "05/19/2020" } ] }