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	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: unknown.H4: device manufacture date: unknown due to unknown lot number.We were unable to determine the details of the actual condition of the sample as it was not available for evaluation.Since the lot number is unknown, an evaluation was not performed.The associates that were tasked to perform specific functions throughout the manufacturing process undergo training and qualification.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.Prior to 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 wings collar, 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.No records were checked since the lot number is unknown.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.Representative 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.We have not confirmed the device failure since the actual sample was not available for evaluation.As the lot is unknown, no records have been confirmed.However, when the representative samples were evaluated, all of the samples were successfully activated, confirming that there were no issues with the sheath's locking mechanism.We perform routine inspections to confirm the performance of the device throughout its manufacturing process; this includes visual and functional checks.We could not identify the root cause of the problem based on our investigation of all the available information regarding this issue.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.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.
Event or Problem Description
Terumo medical corporation received the reported information.A needle stick/injury occurred due to the safety not working properly.No blood loss was reported.
Additional Manufacturer Narrative
D4: lot number: 230213e.D4: expiration date: 31-jan-2028.D4: udi: (b)(4).H4: device manufacture date: 13-feb-2023.This report is being submitted as follow up no.1 to provide additional information to sections d4, h4, and h6, provide the device return date in section d9, update section h3, and provide complete investigation results.The customer sent back the unused samples.Visually, the samples were 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.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.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 wings collar, 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 13 complaints for the same issue affecting 25g needles.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 as being related to our product or manufacturing process.The samples returned by the customer, along with the retention samples, were inspected and confirmed to be free from defects that could affect the activation of the safety sheath, and all samples passed the related functional tests.The lot history files for both lots showed no nonconformities or issues that could impact product quality, and no irregularities were observed during activation when we performed the simulation.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.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.

• 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: 24093892
• Report Number: 3003902955-2025-00122
• Device Sequence Number: 21417759
• Product Code: FMI
• UDI-Device Identifier: 34806017508204
• UDI-Public: (01)34806017508204(17)280331(10)230425E
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 230425E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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 Sex: Unknown