{ "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": 2118 } }, "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": "9612030-2020-02456", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20200404", "reprocessed_and_reused_flag": "I", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "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": "JA", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465347", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "CURITY ANT-REF 14FR WO PVPI", "generic_name": "COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER", "manufacturer_d_name": "COVIDIEN", "manufacturer_d_address_1": "CALLE 9 SUR NO. 125 CUIDAD IND", "manufacturer_d_address_2": "", "manufacturer_d_city": "TIJUANA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "22500", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "MX", "manufacturer_d_postal_code": "22500", "device_operator": "I", "model_number": "8944MF", "catalog_number": "8944MF", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "KNX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10884521050648", "udi_public": "10884521050648", "openfda": { "device_name": "Collector, Urine, (And Accessories) For Indwelling Catheter", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5250", "device_class": "2", "registration_number": [ "9612030" ], "fei_number": [ "3002806934" ] } } ], "product_problems": [ "Deflation Problem", "Deflation Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/17/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200708", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10003347", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200417", "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": "195948972", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "195948973", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT AT PRE-INSERTION BALLOON CHECK, STERILE WATER WOULD NOT COME OUT FROM THE BALLOON AND THE BALLOON WOULD NOT DEFLATE." }, { "mdr_text_key": "319867256", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO THE RELEASE OF PRODUCT. ONE DECONTAMINATED SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE FOR THE INVESTIGATION. VISUAL AND FUNCTIONAL EVALUATIONS WERE PERFORMED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED; STERILE WATER WAS INSERTED INTO THE BALLOON WITH A SYRINGE AND THE BALLOON THEN DEFLATED NORMALLY. A ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTED ISSUE WAS NOT CONFIRMED. THE SAMPLE WAS MANUFACTURED ACCORDING TO CURRENT PRODUCT SPECIFICATIONS, AND TESTED UNDER THE CURRENT ACCEPTANCE CRITERIA. A PRODUCTION NOTIFICATION WAS PERFORMED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES." } ], "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": "07/08/2020" } ] }