MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL); NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	102-N251S3
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: requested, unknown.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: (b)(4) - di only since the lot number is unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: telephone number: requested, unknown.E3: occupation: certified medical assistant (cma).G4: pma/510(k): not available.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 who 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.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.No records were checked since the lot number is unknown.From the previous two fiscal years to the present, we received a total of three (3) complaints for the same issue.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.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 following reported information: the patient came in for an office visit and to receive an influenza vaccine.The nurse administered the vaccine and heard the safety on the needle click, however it still stuck the nurse's finger.The needle seemed to have been a "faulty" needle, or it was a safety malfunction on the needle.The nurse's finger did bleed for a little bit but has stopped.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL)
• 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: 23617724
• Report Number: 3003902955-2025-00106
• Device Sequence Number: 13284530
• Product Code: FMI
• UDI-Device Identifier: 10612479246390
• UDI-Public: (01)10612479246390
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: 102-N251S3
• Device Catalogue Number: N/A
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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