{ "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": "2026-07-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "LAGUNA TECHNOPARK", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "MD", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "BINAN LAGUNA,", "manufacturer_contact_address_1": "950 ELKTON BLVD.", "manufacturer_contact_pcity": "94998904", "event_type": "Malfunction", "report_number": "3003902955-2026-00062", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260630", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20260601", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "21921", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "9499890491", "noe_summarized": "1", "manufacturer_contact_l_name": "HANDY", "source_type": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "4024", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "949", "date_added": "20260630", "manufacturer_contact_f_name": "STEPHANIE", "device_date_of_manufacturer": "20230913", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "368506", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260630", "brand_name": "SURGUARD2 SAFETY HYPODERMIC NEEDLE", "generic_name": "SYRINGE, ANTISTICK", "manufacturer_d_name": "TERUMO PHILIPPINES CORPORATION", "manufacturer_d_address_1": "124 EAST MAIN AVENUE", "manufacturer_d_address_2": "LAGUNA TECHNOPARK", "manufacturer_d_city": "BINAN LAGUNA,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "4024", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "RP", "manufacturer_d_postal_code": "4024", "device_operator": "HEALTH PROFESSIONAL", "model_number": "SG2-2713IMS", "catalog_number": "N/A", "lot_number": "230913B", "other_id_number": "", "device_availability": "No", "device_report_product_code": "MEG", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Syringe, Antistick", "medical_specialty_description": "General Hospital", "regulation_number": "880.5860", "device_class": "2" } } ], "product_problems": [ "Activation Failure" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260630", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9499", "patient": [ { "patient_sequence_number": "1", "patient_problems": [ "Needle Stick/Puncture" ] } ], "distributor_city": "", "date_report": "20260629", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "RP", "manufacturer_contact_city": "ELKTON", "mdr_report_key": "25662219", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260601", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "4024", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "TERUMO PHILIPPINES CORPORATION", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "407281109", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE MALFUNCTION WAS FOR ONE IMS PHYTONADIONE INJECTION UNIT. IT WAS REPORTED THAT AFTER A VITAMIN K ADMINISTRATION, THE SAFETY CAP WAS APPLIED AND THE SYRINGE WAS SET TO THE SIDE. THE REGISTERED NURSE PICKED UP THE SYRINGE TO PUT IT IN A SHARPS CONTAINER. AT THIS TIME, THE SAFETY CAP FELL OFF, AND A NEEDLESTICK OCCURRED THROUGH THE GLOVE." }, { "mdr_text_key": "407281110", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D4: UDI NUMBER: NOT APPLICABLE. D4: EXPIRATION DATE - AUG 2028. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: QUALITY ASSURANCE (QA). G4: PMA/510(K) - NOT AVAILABLE. WE WERE UNABLE TO DETERMINE THE DETAILS OF THE ACTUAL CONDITION OF THE SAMPLE AS IT WAS NOT AVAILABLE FOR EVALUATION. RETENTION SAMPLES WERE VISUALLY INSPECTED AND FOUND TO BE FREE OF ANY DAMAGE OR IRREGULARITIES ON THE SHEATH AND COLLAR. SHEATH ACTIVATION, SHEATH DEACTIVATION, AND COMPONENT FIT TEST WERE PERFORMED ON THE SAMPLES, AND ALL PASSED. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING LOT PRODUCTION. OUR SG NEEDLES WERE ASSEMBLED USING AN AUTOMATED MACHINE WITH VALIDATED PARAMETERS. DURING THE COLLAR ASSEMBLY PROCESS, THE HUB FIT IS LOOSENED FROM THE PROTECTOR BEFORE PLACING THE NEEDLE INTO THE COLLAR. BEFORE PROCEEDING TO THE NEXT PROCESS, THE HUB, CANNULA, AND COLLAR ARE PRESSED INTO THE PROTECTOR, WHEREIN A PHOTOELECTRIC SENSOR DETECTS IF THE HEIGHT OF THE PROTECTOR IS CORRECT. OUR SAFETY NEEDLE FEATURES A HINGED SAFETY SHEATH ATTACHED TO THE NEEDLE HUB. THE SAFETY SHEATH CONTAINS A LOCKING MECHANISM THAT IS ACTIVATED WHEN MANUALLY PRESSED OVER THE NEEDLE IMMEDIATELY AFTER USE AND JUST BEFORE DISPOSAL TO MINIMIZE THE POSSIBILITY OF SHARP INJURY. THE SG2 SAFETY SHEATH IS ACTIVATED WITH A ONE-HANDED OPERATION BY PRESSING THE SHEATH ON A HARD SURFACE WITH FIRM AND QUICK MOTION. AN AUDIBLE AND/OR TACTILE \"CLICK\" INDICATES ACTIVATION, WHICH CAN ALSO BE VISUALLY CONFIRMED. THE COLLAR AND SHEATH UNDERGO AN INITIAL PRODUCT INSPECTION CHECK (IPIC) BEFORE MASS PRODUCTION, DURING RAW MATERIAL CHANGE, MOLD MAINTENANCE, PLANT SHUTDOWN, CAVITY CLOSURE, AND MOLD/PRODUCT TYPE CHANGE. ANY MOLDING DEFECTS THAT MAY AFFECT PRODUCT FUNCTION ARE PART OF THE INSPECTION ITEM. WE ALSO HAVE A VISUAL IN-PROCESS AND PRODUCT CONFIRMATION INSPECTION TO ENSURE THAT THE COLLAR AND SHEATH ARE IN GOOD CONDITION. VISUAL IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO DETECT ABNORMALITIES ON THE PRODUCT THAT MAY CAUSE ISSUES DURING SHEATH ACTIVATION. THE CRITICAL LOCKING PART OF THE SG2 PRODUCT IS CHECKED FOR DEFECTS SUCH AS SHEATH COLLAR FITTING AND OVER- OR UNDER-INSERTION OF THE COLLAR INTO THE HUB. WE HAVE FUNCTIONAL TESTS CONDUCTED TO CONFIRM THAT OUR PRODUCTS ARE FREE OF DEFECTS THAT WOULD LEAD TO DIFFICULTY OR FAILURE OF DEVICE ACTIVATION. WE PERFORM SAFETY SHEATH ACTIVATION DURING SG ASSEMBLY INSPECTION AND OUTGOING INSPECTION OF FINISHED PRODUCTS, WHERE THE CANNULA SHOULD BE CAPTURED UNDER THE SHEATH'S TOOTH. DURING THE COMPONENT FIT TEST, WE ALSO CHECK THAT THE SHEATH LUGS ARE SECURELY ATTACHED TO THE COLLAR EAR. BEFORE SHIPMENT, QC CONDUCTS OUTGOING INSPECTIONS TO CHECK THE OVERALL CONDITION OF THE PRODUCTS. THE COLLAR IS MANUFACTURED IN-HOUSE WITH VALIDATED TPC MOLDING MACHINES. THERE WERE NO NONCONFORMANCE REPORTS ISSUED FOR THE SUPPLIED MOLDED PART LOTS. OUR SAFETY SHEATH HAS UNDERGONE INCOMING INSPECTION, WHICH INCLUDES VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND VERIFICATION OF THE SUPPLIER'S CERTIFICATE. THIS IS THE FIRST TIME WE HAVE RECEIVED A COMPLAINT FOR SG2 NEEDLES FROM FY24. RETENTION SAMPLES WERE SIMULATED. THE SAMPLES WERE ACTIVATED USING HARD SURFACE ACTIVATION. ALL OF THE SAMPLES WERE SUCCESSFULLY ACTIVATED, AND THE CANNULA WAS CAPTURED UNDER THE SHEATH TOOTH. THERE WERE NO IRREGULARITIES ENCOUNTERED DURING THE ACTIVATION. WE HAVE NOT CONFIRMED THE DEVICE FAILURE SINCE THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, WHEN THE RETENTION SAMPLES WERE EVALUATED, ALL OF THE SAMPLES WERE SUCCESSFULLY ACTIVATED, CONFIRMING THAT THERE WERE NO ISSUES WITH THE SHEATH'S LOCKING MECHANISM. THE LOT HISTORY FILE SHOWED NO NON-CONFORMITY OR ANY RELATED TROUBLES THAT WOULD AFFECT THE PRODUCT QUALITY. WE PERFORM ROUTINE INSPECTIONS TO CONFIRM THE PERFORMANCE OF THE DEVICE THROUGHOUT ITS MANUFACTURING PROCESS; THIS INCLUDES VISUAL AND FUNCTIONAL CHECKS. WE HAVE ROUTINE INSPECTIONS TO CHECK THE CONDITION OF THE PRODUCTS. THE COMPONENTS THAT ARE CRITICAL TO THE PRODUCT'S SAFETY ACTIVATION ARE CHECKED TO ENSURE THAT NO DEFECTS OCCUR THAT COULD RESULT IN SHEATH ACTIVATION ISSUES. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "124 EAST MAIN AVENUE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "21921", "manufacturer_contact_exchange": "949", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }