{ "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": 879 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "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": "Other", "report_number": "1119779-2008-00004", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080311", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080212", "reprocessed_and_reused_flag": "N", "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": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20080829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080311", "brand_name": "BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT", "generic_name": "", "manufacturer_d_name": "BD DIAGNOSTICS", "manufacturer_d_address_1": "250 SCHILLING CIR.", "manufacturer_d_address_2": "", "manufacturer_d_city": "COCKEYSVILLE", "manufacturer_d_state": "MD", "manufacturer_d_zip_code": "21030", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "21030", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20081111", "model_number": "", "catalog_number": "297292", "lot_number": "7323024", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080218", "device_report_product_code": "JSG", "device_age_text": "DA", "device_evaluated_by_manufacturer": "*", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Culture Media, Non-Selective And Non-Differential", "medical_specialty_description": "Microbiology", "regulation_number": "866.2300", "device_class": "1", "registration_number": [ "1119779" ], "fei_number": [ "1119779" ] } } ], "product_problems": [ "Sticking" ], "reporter_state_code": "RI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20080311", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Surgical procedure", "Cut(s)" ] } ], "distributor_city": "", "date_report": "20080310", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1011985", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080212", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "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": "837172", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "CUSTOMER CALLED TO REPORT THAT ABOUT HALF OF HER BOX OF 100 TUBES WERE TOO TIGHT AND HARD TO GET OPEN. ONE OF HER LAB ASSISTANCE HAD A TUBE BREAK IN HER HANDS UPON TRYING TO OPEN IT AND CUT HER THUMB REQUIRING STITCHES." }, { "mdr_text_key": "8029343", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "SEVEN TUBES FROM THIS LOT WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. TWO TUBES WERE OPENED BY HAND; ONE WAS EASY TO PEN AND THE OTHER WAS DIFFICULT. THE REMAINING FIVE TUBES WERE TESTED FOR TORQUE WITH READINGS FROM 4.6 TO 7.6 IN/LB. THE SATISFACTORY RANGE IS 3.0-8.0 IN/LB WITH A TARGET OF 5.5 IN/LB. ADDITIONALLY, THE DIFFICULT TO OPEN TUBES WERE MEASURED FOR CRITICAL DIMENSIONS AND FOUND TO BE WITHIN SPEC. RETENTION SAMPLES WERE TESTED FOR EASE TO OPEN AND TORQUE. TUBES WERE EASILY OPENED BY A LAB TECH AND THE TORQUE TESTING RESULTS WERE BETWEEN 1.3 TO 5.7 IN/LB. THE BATCH HISTORY RECORD WAS EXAMINED AND FOUND TO BE SATISFACTORY WITH ALL TORQUE READINGS BETWEEN 4.5 AND 6.4 IN/LB DURING FILLING. A REVIEW OF THE COMPLAINT SYS WAS CONDUCTED AND SHOW NO OTHER REPORTED OF THIS DEFECT ON THIS PROD LOT. THIS LOT WILL BE MONITORED FOR FUTURE REPORTS OF THIS DEFECT. A CORRECTIVE ACTION HAS BEEN OPENED TO FURTHER ADDRESS THIS ISSUE." } ], "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": "" } ] }