BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 23877460 · Received December 23, 2025

    Report

    Report Number
    3003902955-2025-00111
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 23, 2025
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K152362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4: WEIGHT: REQUESTED, NOT PROVIDED , A5: ETHNICITY: REQUESTED, NOT PROVIDED, A6: RACE: REQUESTED, NOT PROVIDED, D4: LOT NUMBER: POTENTIAL LOTS: 230906C, 230511D, D4: EXPIRATION DATE: POTENTIAL DATES: 31-AUG-2028, 30-APR-2028, D4: UDI: (B)(4), D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, E1: CONTACT: UNKNOWN, E1: ADDRESS: UNKNOWN, E1: TELEPHONE NUMBER: UNKNOWN, H4: DEVICE MANUFACTURE DATE: POTENTIAL DATES: 06-SEP-2023, 11-MAY-2023. 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 FROM FOREIGN MATERIAL AND ANY OTHER CONTRIBUTING DEFECTS THAT COULD HAVE LED TO THE COMPLAINT. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING LOTS PRODUCTION. OUR SG NEEDLES WERE ASSEMBLED USING AN AUTOMATED MACHINE WITH VALIDATED PARAMETERS. DURING THE NEEDLE ASSEMBLY PROCESS, THE NEEDLES ARE ADHERED TO THE HUB WITH AN ADHESIVE AGENT AND LUBRICANT FOR SMOOTH NEEDLE PENETRATION. THIS IS DONE BY DIPPING THE NEEDLE INTO A TRAY WITH SILICONE. WE HAVE AN AIR-BLOWING PROCESS TO REMOVE SILICONE INSIDE THE CANNULA DURING DIPPING. AFTER THIS PROCESS, THE NEEDLES WILL AGAIN PASS THROUGH A SERIES OF AIR BLOWING TO ENSURE THE REMOVAL OF ANY REMAINING EXCESS SILICONE ON THE CANNULA. WE HAVE AN AUTOMATIC NEEDLE TIP INSPECTION SYSTEM DURING NEEDLE ASSEMBLY THAT CAN DETECT AND AUTOMATICALLY REJECT DAMAGED NEEDLE TIPS MORE THAN 40 MICROMETER. DUMMY CHECKS ARE PERFORMED ON THESE SENSORS TWICE A WEEK TO ENSURE THE ACCURACY OF THE INSPECTION SYSTEM. OUR PRODUCT'S STAINLESS NEEDLE IS COATED WITH A LUBRICANT AND ADHERED TO THE DEVICE USING A HIGHLY VISCOUS ADHESIVE OR BONDING AGENT. THE DEVICE IS NON-TOXIC, OR DOES NOT CONTAIN ANY TOXINS OR HARMFUL SUBSTANCES THAT ARE POISONOUS, AND DOES NOT CONTAIN COMPONENTS MADE OF NATURAL RUBBER LATEX. IT IS ALSO PYROGEN-FREE AND THEREFORE DOES NOT CONTAIN ANY DRUG IMPURITY THAT, WHEN INJECTED INTO THE BLOODSTREAM, MAY CAUSE FEVER. THE SG3 NEEDLE IS INDIVIDUALLY PACKED IN A BLISTER TO KEEP THE PRODUCT STERILE. OUR PRODUCTS MEET ISO 7864 STANDARDS, INCLUDING LIMITS FOR ACIDITY, ALKALINITY, AND EXTRACTABLE METALS. WE COMPLY WITH THE REQUIREMENTS OF ISO 10993 FOR TESTING AND DETERMINING THE BIOCOMPATIBILITY OF THE NEEDLES. DURING THE CANNULA INSPECTION, THE SUPPLIED CANNULA RAW MATERIAL HAS UNDERGONE AN OVERALL INSPECTION. DEFECTIVE SAMPLES FOUND WILL BE SEGREGATED AND DISCARDED ACCORDINGLY. IF ANY UNUSUAL CANNULA CONDITION IS FOUND, A NONCONFORMITY REPORT SHALL BE ISSUED. NO NONCONFORMITY REPORT WAS NOTED ON THE INVOLVED CANNULA LOTS. QC CONDUCTS MONTHLY PHYSICAL AND CHEMICAL TESTS ON STERILE PRODUCTS USING THE PHYSICOCHEMICAL TEST. THE TEST ITEMS INCLUDE ACIDITY/ALKALINITY TESTS, EXTRACTABLE METALS, AND METAL TRACES SUCH AS CADMIUM, LEAD, IRON, ZINC, AND TIN. VISUAL IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO INSPECT FOR BURRS OR BENT POINTS, TIP DAMAGE, AND FOREIGN MATERIAL IN THE PRODUCT. WE PERFORM THE CANNULA PENETRATION TEST DURING NEEDLE ASSEMBLY AND THE DENTAL DAM TEST DURING THE SG ASSEMBLY PROCESS TO CHECK THE CONDITION OF THE NEEDLE TIP. OUR FINISHED PRODUCTS UNDERGO BACTERIAL ENDOTOXIN LEVEL TESTING TO ENSURE THEY ARE FREE OF BACTERIAL ENDOTOXIN. ALL FINISHED PRODUCTS UNDERGO ELECTRON BEAM STERILIZATION. THE ABSORBED DOSE IS MEASURED FOR EVERY STERILIZATION BATCH. AS PART OF OUR MICROBIOLOGICAL TESTING, STERILITY TESTS WERE CONDUCTED ON OUR SG3 PRODUCTS EVERY QUARTER. ADDITIONALLY, A STABILITY TEST INSPECTION WAS PERFORMED, WHICH INCLUDED AN ANNUAL STERILITY TEST STARTING FROM THE PRODUCTION DATE UNTIL THE FIFTH YEAR. WE HAVE SET CLEANING FREQUENCIES IN THE AREA, INCLUDING MACHINES, TOOLS, AND EQUIPMENT, TO ENSURE THE CLEANLINESS AND QUALITY OF PRODUCTS. BEFORE SHIPMENT, QC CONDUCTS OUTGOING INSPECTIONS TO CHECK THE OVERALL CONDITION OF THE PRODUCTS. .THE SUPPLIED CANNULA RAW MATERIAL IS TPC INSPECTED, WHEREIN THE OVERALL VISUAL CONDITION OF THE CANNULA HAS BEEN CHECKED. FROM THE PREVIOUS TWO FISCAL YEARS TO THE PRESENT, WE RECEIVED A TOTAL OF TWELVE (12) COMPLAINTS FOR THE SAME ISSUE. THE CAUSE OF THESE COMPLAINTS WAS NOT IDENTIFIED AS BEING RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT IS NOT RELATED TO OUR PRODUCT OR PRODUCTION PROCESS. OUR SG3 NEEDLE IS NON-TOXIC AND DOES NOT CONTAIN ANY TOXINS POISONOUS SUBSTANCES. IT IS ALSO FREE OF PYROGENS, WHICH MEANS IT CONTAINS NO SUBSTANCES THAT CAN CAUSE FEVER WHEN INJECTED INTO THE BLOODSTREAM. THE RETENTION SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED TO BE FREE FROM FOREIGN MATERIAL AND ANY OTHER CONTRIBUTING DEFECTS THAT COULD HAVE LED TO THE COMPLAINT. OUR NEEDLES FOLLOW THE REQUIREMENTS SET ON ISO 7864 AND ISO 10993. EVERY LOT IS TESTED FOR THE PRESENCE OF BACTERIAL ENDOTOXIN TO ENSURE THAT OUR PRODUCTS ARE SAFE TO USE AND WILL NOT CAUSE ANY HARM. WE ALSO HAVE MONTHLY PHYSICOCHEMICAL TESTS TO CHECK FOR METAL AND ALKALINE TRACES. CLEANLINESS IS MAINTAINED INSIDE THE PRODUCTION AREA TO ENSURE THAT THE PRODUCTS ARE FREE FROM FOREIGN MATERIAL CONTAMINATION. ALL FINISHED PRODUCTS ARE STERILIZED USING THE ELECTRON BEAM STERILIZATION PROCESS, AND QC PERFORMS OUTGOING INSPECTION BEFORE SHIPMENT TO ENSURE THE OVERALL CONDITION OF THE NEEDLES. ADDITIONALLY, STERILITY TESTS ARE CONDUCTED QUARTERLY FOR MICROBIOLOGICAL TESTING AND ANNUALLY FOR STABILITY TEST INSPECTIONS. THESE CONFIRM THE EFFECTIVENESS OF OUR STERILIZATION PROCESS. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955.

    Description of Event or Problem · 0

    TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE NURSE REPORTED THAT THE PATIENT HAD INJECTION SITE REACTIONS WHEN INJECTED WITH SUBLOCADE. INJECTION WAS GIVEN ON THE LUQ BY ANOTHER NURSE. PATIENT HAD HER INJECTION ON (B)(6) 2025. SHE PRESENTED TO THE CLINIC ON (B)(6) 2025, WITH AN OPEN, RED, PURULENT, AND PAINFUL ABSCESS AT THE INJECTION SITE. SHE STARTED NOTICING THE REACTION 2 DAYS POST-INJECTION. THIS IS NOT HER FIRST INJECTION. FIRST DOSE WAS ON (B)(6) 2025, SECOND INJECTION ON (B)(6) 2025. SHE IS ON SUBLOCADE FOR OUD. PATIENT WAS ALSO PUT ON DOXYCYCLINE HYCLATE 100MG BID FOR 7 DAYS. THE WOUND IS HEALING. PATIENT IS ON LISINOPRIL 10MG, HYDROCHLOROTHIAZIDE 12.5MG, AND LEVOTHYROXINE 112MCG ONE TABLET DAILY. THE PATIENT DOES NOT HAVE A HISTORY OF INJECTION SITE REACTIONS; THE NURSE CONSIDERS THE REACTION AS SEVERE. THE NURSE STATED THAT ANOTHER NURSE ADMINISTERED THE INJECTION, AND THERE WERE NO COMPLICATIONS. SHE ADDED THAT SHE ADMINISTERED LIDOCAINE 3ML SC BEFORE THE INJECTION, SO THE INJECTION WAS PAIN-FREE. ADDITIONAL INFORMATION WAS RECEIVED ON 04DEC2025: SHE REPORTED THAT SHE USED LIDOCAINE 3ML WITH THE INJECTION AND PATIENT HAD ADEQUATE SUBCUTANEOUS TISSUE. THE PATIENT CONDITION WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057306 SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION SG3+1916

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention SUBLOCADE 300MG INJECTION