BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGUARD2 SAFETY HYPODERMIC NEEDLE

    MDR report key: 23572575 · Received November 17, 2025

    Report

    Report Number
    3003902955-2025-00093
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 17, 2025
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED, A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED, A3A: SEX: REQUESTED, NOT PROVIDED, A4: WEIGHT: REQUESTED, NOT PROVIDED, A5: ETHNICITY: REQUESTED, NOT PROVIDED, A6: RACE: REQUESTED, NOT PROVIDED, D4: LOT NUMBER: POTENTIAL LOTS: 230607B, 230503B, D4: EXPIRATION DATE: POTENTIAL DATES: 31-MAY-2028, 30-APRIL-2028, D4: UDI NUMBER: NOT APPLICABLE, D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, E3: OCCUPATION: QUALITY ASSURANCE IMS, H4: DEVICE MANUFACTURE DATE: POTENTIAL LOTS: 07-JUN-2023, 03-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 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 LOTS PRODUCTION. THERE ARE NO NONCONFORMITIES IN THE ASSEMBLED NEEDLE LOTS SUPPLIED DURING PRODUCTION. 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 UNDERGOES 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 IS 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. FROM THE PREVIOUS TWO FISCAL YEARS TO THE PRESENT, WE RECEIVED A TOTAL OF TWO (2) COMPLAINTS FOR THE SPECIFIC ITEM CODE. THE CAUSE OF THESE COMPLAINTS WAS NOT IDENTIFIED AS BEING RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. RETENTION SAMPLES OF 27G WERE SIMULATED. THE SAMPLES WERE ACTIVATED BY PRESSING THE SHEATH ON A HARD SURFACE WITH A FIRM AND QUICK MOTION. ALL THE SAMPLES WERE SUCCESSFULLY ACTIVATED, AND THE CANNULA WAS CAPTURED UNDER THE SHEATH TOOTH. THERE WERE NO IRREGULARITIES ENCOUNTERED DURING THE ACTIVATION. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED TO BE RELATED TO OUR PRODUCT OR MANUFACTURING PROCESS. THE LOT'S HISTORY FILE SHOWED NO NON-CONFORMITY OR ANY RELATED TROUBLES THAT WOULD AFFECT THE PRODUCT QUALITY. THE RETENTION SAMPLES WERE INSPECTED AND CONFIRMED TO BE FREE FROM DEFECTS THAT WOULD AFFECT THE ACTIVATION OF THE SAFETY SHEATH AND PASSED THE FUNCTIONAL TEST. ALSO, THERE WERE NO IRREGULARITIES ENCOUNTERED DURING THE ACTIVATION WHEN WE PERFORMED THE SIMULATION. WE PERFORM ROUTINE INSPECTIONS TO CONFIRM THE PERFORMANCE OF THE DEVICE THROUGHOUT ITS MANUFACTURING PROCESS, WHICH INCLUDES VISUAL AND FUNCTIONAL CHECKS. WE RECOMMEND FOLLOWING THE CORRECT ACTIVATION OF THE SG2 NEEDLE TO AVOID SHEATH ACTIVATION FAILURES AND NEEDLESTICKS. (B)(4) (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 FOLLOWING REPORTED INFORMATION: THERE WAS A MALFUNCTION THAT INVOLVED ONE IMS PHYTONADIONE INJECTION UNIT MANUFACTURED WITH A TERUMO SURGUARD 2 NEEDLE HUB. THE NEEDLE SAFETY SYSTEM FOR ONE SYRINGE DID NOT ENGAGE, RESULTING IN AN UNSECURED NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 22OCT2025: THERE WAS NO REPORTED INCIDENT OF A NEEDLE STICK. THERE WAS NO REPORTED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289609 SURGUARD2 SAFETY HYPODERMIC NEEDLE SYRINGE, ANTISTICK MEG TERUMO PHILIPPINES CORPORATION SG2-2713IMS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IMS PHYTONADIONE INJECTION