{ "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": { "skip": 0, "limit": 1, "total": 27926 } }, "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": "1018233-2020-02858", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K910846", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "OTHER", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "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": "467246", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER", "generic_name": "FOLEY TRAY KIT", "manufacturer_d_name": "C.R. BARD, INC. (COVINGTON) -1018233", "manufacturer_d_address_1": "8195 INDUSTRIAL BLVD", "manufacturer_d_address_2": "", "manufacturer_d_city": "COVINGTON", "manufacturer_d_state": "GA", "manufacturer_d_zip_code": "30014", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "30014", "device_operator": "HEALTH PROFESSIONAL", "model_number": "902916", "catalog_number": "902916", "lot_number": "UNK", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EZC", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00801741024863", "udi_public": "(01)00801741024863", "openfda": { "registration_number": [ "1018233" ], "fei_number": [ "1018233" ], "device_name": "Catheter, Coude", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5130", "device_class": "2" } } ], "product_problems": [ "Gel Leak", "Gel Leak", "Leak/Splash" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/07/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250725", "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 Known Impact Or Consequence To Patient", "No Patient Involvement", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200513", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002217", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "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": "317735970", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE REPORTED EVENT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿LEAKAGE¿ WITH A POTENTIAL ROOT CAUSE OF ¿TIP COVER CAME OFF DURING SHIPPING OR IN PROCESSING¿. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: \"BARD® EZ-LOK® SAMPLING PORT (INDICATED BY THE BLUE STEM IN THE PORT) ACCEPTS LUER LOCK (FIG. 1A) OR SLIP TIP SYRINGES (FIG. 1B). 1. OCCLUDE DRAINAGE TUBING A MINIMUM OF 3 INCHES BELOW THE SAMPLING PORT BY KINKING THE TUBING UNTIL URINE IS VISIBLE UNDER THE ACCESS SITE. 2. SWAB SURFACE OF BARD® EZ-LOK® SAMPLING PORT WITH ANTISEPTIC WIPE. (FIG. 2) 3. USING ASEPTIC TECHNIQUE, POSITION THE SYRINGE IN THE CENTER OF THE SAMPLING PORT. PRESS THE SYRINGE FIRMLY AND TWIST GENTLY TO ACCESS THE SAMPLING PORT. (FIG. 3) 4. SLOWLY ASPIRATE URINE SAMPLE INTO SYRINGE AND REMOVE SYRINGE FROM SAMPLE PORT. 5. UNKINK TUBING IF NECESSARY AND TRANSFER URINE SPECIMEN INTO SPECIMEN CUP OR FOLLOW HOSPITAL PROTOCOL. DISCARD SYRINGE ACCORDING TO HOSPITAL PROTOCOL. 6. FOLLOW ESTABLISHED HOSPITAL PROTOCOL FOR SPECIMEN LABELING AND TRANSPORT TO LAB. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE.\" 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED." }, { "mdr_text_key": "317735971", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT AS REPORTED THAT UPON OPENING THE KIT, HEALTH PROFESSIONALS NOTICED 10 CC SYRINGE OF STERILE WATER HAD LEAKED OUT, LEAVING APPROXIMATELY 0.5 CC STERILE WATER LEFT IN THE SYRINGE." }, { "mdr_text_key": "189306298", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED." }, { "mdr_text_key": "189306299", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT UPON OPENING THE KIT, HEALTH PROFESSIONALS NOTICED 10 CC SYRINGE OF STERILE WATER HAD LEAKED OUT, LEAVING APPROXIMATELY 0.5 CC STERILE WATER LEFT IN THE SYRINGE." } ], "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": "05/13/2020" } ] }