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

Model Number	SG3-2525
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: requested, 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 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.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.Our product has an allowable tilting of the needle of not more than 2°.Tilted cannulas are one of the check items in the hourly in-process inspection during needle assembly.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.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.It undergoes 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 107 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.The representative samples were injected into the dummy arm's veins and a rubber cork to simulate intravenous and intramuscular injections prior to safety activation.The safety sheath was successfully activated on the samples; the needle did not bend out of the sheath, and no difficulties were encountered.In the next simulation, the needle was forcefully injected into the cork, causing it to slightly bend.Despite being bent, the sheath-tooth was able to completely capture the cannula, and the collar wing was fully locked on the sheath, indicating that the activation was successful.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.We were unable to recreate the device failure when we performed the simulation.Although the needle was forcefully injected and was slightly bent, there was still successful activation.The cannula did not bend out of the sheath.We could not identify the root cause of the problem based on our investigation of all the available information regarding this issue.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.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 defect was in the safety locking mechanism.The needle tip can remain exposed even after attempting to lock it, which posed a significant risk for accidental needle sticks.No injuries or blood loss was reported.

• 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: 24560169
• Report Number: 3003902955-2026-00016
• Device Sequence Number: 21047971
• Product Code: FMI
• UDI-Device Identifier: 34806017508204
• UDI-Public: (01)34806017508204
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/10/2026
• 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