{ "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": 343 } }, "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": "2916714-2020-00131", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K890759", "date_of_event": "20180810", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "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": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "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": "465072", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "STEAM STER LOCKS ORANGE", "generic_name": "STERILE TECHNOLOGY", "manufacturer_d_name": "SPS MEDICAL (CROSSTEX)", "manufacturer_d_address_1": "6789 W. HENRIETTA ROAD", "manufacturer_d_address_2": "", "manufacturer_d_city": "RUSH, NY", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "US906", "catalog_number": "US906", "lot_number": "1803008", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KCT", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "2916714" ], "fei_number": [ "2916714" ], "device_name": "Sterilization Wrap Containers, Trays, Cassettes & Other Accessories", "medical_specialty_description": "General Hospital", "regulation_number": "880.6850", "device_class": "2" } } ], "product_problems": [ "Material Integrity Problem", "Material Integrity Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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 Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10002953", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20180810", "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": "191835161", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "CROSSTEX (SPS) RECEIVED A COMPLAINT IN WHICH IT WAS REPORTED THAT US906 STEAM INDICATOR DOTS (LOTS 1803008 AND 580031-01) WERE FAILING TO TRANSITION IN COLOR DURING STERILIZATION. IT WAS NOTED THAT THERE HAS BEEN NO PATIENT INJURY AND NO SURGICAL DELAY WAS REPORTED. REVIEW OF PRODUCTION BATCH RECORDS ASSOCIATED WITH BOTH THE RECEIPT TESTING OF CHEMICAL INDICATOR INK AS WELL AS TESTING OF FINISHED GOODS SHOWED NO NON-CONFORMANCES. PRODUCT OPERATED AS INTENDED THROUGHOUT THE MANUFACTURING AND PRODUCT RELEASE PROCESS. UPON RECEIPT OF THE RETURNED SUSPECT PRODUCT, TESTING OF FACTORY RETAINS FROM LOT 1803008 AS WELL AS SAMPLES FROM THE RETURNED PRODUCT WAS CONDUCTED. REVIEW OF ALL SAMPLES PROCESSED SHOWED THAT THE PRODUCT IN BOTH CASES TRANSITIONED AND PERFORMED AS INTENDED. FURTHER REVIEW OF COMPLAINTS ASSOCIATED WITH LOT 1803008 WAS PERFORMED WITH NO VERIFIED COMPLAINTS. THIS ISSUE AGAINST LOT 1803008 HAS BEEN LOGGED WITHIN THE COMPLAINT SYSTEM AND WILL BE MONITORED FOR RECURRENCE. ALL COMPLAINTS AGAINST THIS LOT WILL BE TESTED IN SIMILAR FASHION, AND SHOULD A COMPLAINT BE VERIFIED CROSSTEX WILL RE-EVALUATE THE ISSUE AND REOPEN OTHER ASSOCIATED COMPLAINTS FOR ADDITIONAL INVESTIGATION AS APPLICABLE. NOTE: A RETROSPECTIVE REVIEW OF POTENTIAL SERIOUS INJURY COMPLAINTS WAS PERFORMED. THIS MDR WAS IDENTIFIED AS A REPORTABLE MALFUNCTION AS A RESULT AND FILED AS PART OF THE REVIEW ACTIVITIES." }, { "mdr_text_key": "191835162", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THERE WAS AN ISSUE WITH THE ORANGE LOCKS. THE REPORTER INDICATED THAT THE COLOR ON THE ORANGE TAGS DID NOT CHANGE DURING STERILIZATION. THIS HAS HAPPENED WITH SEVERAL LOCKS FROM VARIOUS LOT NUMBERS. NO PATIENT INJURY. NO DELAY IN SURGERY." } ], "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": "" } ] }