{ "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": 386 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "Y", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "10000519", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20171101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "report_date": "20200303", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "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": "463555", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "COMPLY", "generic_name": "INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS", "manufacturer_d_name": "3M", "manufacturer_d_address_1": "3M CENTER, 2510 CONWAY AVE BLDG. 275-5W-06", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAINT PAUL", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55144", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55144", "device_operator": "I", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No answer provided", "device_report_product_code": "JOJ", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Indicator, Physical/Chemical Sterilization Process", "medical_specialty_description": "General Hospital", "regulation_number": "880.2800", "device_class": "2" } } ], "product_problems": [ "Product Quality Problem" ], "reporter_state_code": "OR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250728", "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 Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20171116", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "date_report_to_manufacturer": "20200427", "manufacturer_contact_city": "", "mdr_report_key": "10000519", "removal_correction_number": "", "number_devices_in_event": "", "date_report_to_fda": "20200303", "manufacturer_name": "", "report_source_code": "User Facility 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": "188994690", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "WE HAVE A POTENTIAL SAFETY ISSUE REGARDING THE PRODUCTS USED IN HYDROGEN PEROXIDE STERILIZATION . 3M AND AESCULAP MAKE PRODUCTS FOR THE HYDROGEN PEROXIDE STERILIZATION AND THEY ARE OPPOSITE IN THE COLORS DESIGNATING PROCESSED AND UNPROCESSED. NEITHER COMPANY MAKES ALL THE PRODUCTS. 3 M MAKES THE PRODUCTS USED FOR WRAPPED ITEMS; GO FROM BLUE (UNPROCESSED/UNSTERILIZED) TO PINK (PROCESSED/STERILIZED) WHEREAS THE PRODUCTS FROM OTHER MANUFACTURER (AESCULAP) USED FOR OUTSIDE METAL CONTAINERS; GO FROM PINK (UNPROCESSED /UNSTERILIZED) TO BLUE (PROCESSED/STERILIZED). STERILE PROCESSING MANAGER HAVE CONTACTED BOTH VENDORS REGARDING THE IDENTIFIED PATIENT SAFETY RISK AND THE SUBSEQUENT ANGST OF THE PROCEDURAL CAREGIVERS. WE HAVE ASKED BOTH VENDORS TO RESPOND TO THIS OPPORTUNITY BY DEVELOPING A NEW PRODUCT LINE OR COLLABORATE WITH EACH OTHER TO STANDARDIZE THE PROCESS COLORS. AWAITING RESPONSE FROM VENDORS." } ], "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": "" } ] }