MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	SG3-2525
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical corporation received the following reported information: the safety cover did not fully engage after the needle was placed down after the injection was administered.Punctured skin through the glove.Additional information was received on 26dec2025: the patient received the vaccine as intended.The staff member followed up at bmc occupational health.There was no impact on the patient's health.Additional information was received on 06jan2026: the activation was on a hard surface.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A4: weight: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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, collar, and hub.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.There are no nonconformities in the assembled needle lot 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 two locking mechanisms, the sheath tooth-cannula and sheath wingscollar, which are simultaneously activated when manually pressed over the needle immediately after use and just before disposal to minimize the possibility of sharps injury.The locking mechanisms are positioned within the center and the proximal end of the sheath.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 sg3 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 product's instructions for use (ifu) provide detailed instructions for using the sg3 safety needle device, including warnings to prevent needle sticks.The collar and sheath are manufactured in-house with validated tpc molding machines.There were no nonconformance reports issued for the supplied molded part lots.From the previous two fiscal years to the present, we received a total of 11 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 25g needles were simulated.The samples were activated using three methods: finger, thumb, and 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.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 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 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.We recommend following the instructions for use (ifu) for proper use of the sg3 needle, which includes caution, precautions, and warnings to avoid problems during sheath activation.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan laguna, 4024 ; RP 4024
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan laguna, 4024 ; RP 4024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24052742
• Report Number: 3003902955-2025-00120
• Device Sequence Number: 9494987
• Product Code: FMI
• UDI-Device Identifier: 34806017508204
• UDI-Public: (01)34806017508204(17)280831(10)230919C
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SG3-2525
• Device Catalogue Number: N/A
• Device Lot Number: 230919C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White