{ "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": 114961 } }, "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": "3006425876-2020-00354", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K993933", "date_of_event": "20200410", "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": [ "DISTRIBUTOR", "FOREIGN", "HEALTH PR" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "KS", "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": "463619", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM", "generic_name": "CATHETER HEMODIALYTSIS NON IMP", "manufacturer_d_name": "ARROW INTERNATIONAL INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "READING", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "CS-22122-F", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200428", "device_report_product_code": "MPB", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Catheter, Hemodialysis, Non-Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2", "registration_number": [ "3006425876" ], "fei_number": [ "3006425876" ] } } ], "product_problems": [ "Difficult to Insert", "Material Deformation", "Difficult to Insert", "Material Deformation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250825", "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 Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200413", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001151", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200413", "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": "189053568", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "189053569", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTS: THE MIDDLE OF THE GUIDEWIRE WAS BENT AND COULDN'T GET IN. THE MD TOOK OUT ANOTHER NEW PRODUCT AND FINISHED THE PROCEDURE." }, { "mdr_text_key": "316978636", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(B)(4). THE CUSTOMER RETURNED AN OPENED HEMODIALYSIS KIT CONTAINING A SPRING WIRE GUIDE (SWG) WITHIN ITS ADVANCER TUBING, CATHETER, DILATOR, ARS, INTRODUCER NEEDLE, AND VARIOUS OTHER COMPONENTS FOR EVALUATION. VISUAL INSPECTION OF THE SWG REVEALED ONE KINK IN ITS BODY. MICROSCOPIC EXAMINATION OF THE SWG CONFIRMED THE KINK AND THAT BOTH WELDS WERE IN PLACE. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED IN THE OTHER COMPONENTS. THE KINK IN THE SWG BODY WAS MEASURED AT 453 MM FROM THE PROXIMAL WELD. THE TOTAL LENGTH OF THE SWG MEASURED 601 MM, WHICH IS WITHIN SPECIFICATIONS OF 596-604 MM PER SWG GRAPHIC. THE OUTER DIAMETER OF THE SWG MEASURED 0.854 MM WHICH IS WITHIN SPECIFICATIONS OF 0.838-0.877 MM PER SWG GRAPHIC. THE SWG WAS INSERTED INTO THE RETURNED ARS, 18 GA INTRODUCER NEEDLE, CATHETER, AND DILATOR TO FUNCTIONALLY TEST. THE SWG ONLY ENCOUNTERED RESISTANCE AT THE KINK FOR ALL FOUR COMPONENTS. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, \"DO NOT APPLY EXCESSIVE FORCE IN REMOVING GUIDE WIRE OR CATHETERS. IF WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, A CHEST X-RAY SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED.\" THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE CONTAINED ONE KINK IN ITS BODY. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS AND A DEVICE HISTORY RECORD REVIEW BASED ON SALES HISTORY DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE." }, { "mdr_text_key": "316978637", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CUSTOMER REPORTS: THE MIDDLE OF THE GUIDEWIRE WAS BENT AND COULDN'T GET IN. THE MD TOOK OUT ANOTHER NEW PRODUCT AND FINISHED THE PROCEDURE." } ], "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": "05/20/2020" } ] }