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

Model Number	SG3+1916
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injection Site Reaction (4562)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age or 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.B3: date of event: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: quality records co-ordinator- cw.The details of the actual condition were unable to be determined as the actual sample was not available for evaluation.Retention samples were visually inspected and found to be free from foreign material and any other contributing defects that could have led to the complaint.There was no issued nonconformity report related to human error during lot production.Our sg needles were assembled using an automated machine with validated parameters.During the needle assembly process, the needles are adhered to the hub with an adhesive agent and lubricant for smooth needle penetration.This is done by dipping the needle into a tray with silicone.We have an air-blowing process to remove silicone inside the cannula during dipping.After this process, the needles will again pass through a series of air blowing to ensure the removal of any remaining excess silicone on the cannula.We have an automatic needle tip inspection system during needle assembly that can detect and automatically reject damaged needle tips more than 40um.Dummy checks are performed on these sensors twice a week to ensure the accuracy of the inspection system.Our product's stainless needle is coated with a lubricant and adhered to the device using a highly viscous adhesive or bonding agent.The device is non-toxic or does not contain any toxins or harmful substances that are poisonous and does not contain components made of natural rubber latex.It is also pyrogen-free and therefore does not contain any drug impurity that, when injected into the bloodstream, may cause fever.Sg3 needle is individually packed in a blister to keep the product sterile.Our products meet iso 7864 standards, including limits for acidity, alkalinity, and extractable metals.We comply with the requirements of iso 10993 for testing and determining the biocompatibility of the needles.During the cannula inspection, the supplied cannula raw material has undergone overall inspection.Defective samples found will be segregated and discarded accordingly.If any unusual cannula condition was found, a nonconformity report shall be issued.No nonconformity report was noted on the involved cannula lot.Qc conducts monthly physical and chemical tests on sterile products using the physicochemical test.The test items include acidity/alkalinity tests, extractable metals, and metal traces such as cadmium, lead, iron, zinc, and tin.Visual in-process inspections are conducted during the manufacturing process to inspect for burrs or bent points, tip damage, and foreign material in the product.We perform the cannula penetration test during needle assembly and the dental dam test during the sg assembly process to check the condition of the needle tip.Our finished products undergo bacterial endotoxin level testing to ensure they are free of bacterial endotoxin.All finished products undergo electron beam sterilization.The absorbed dose is measured for every sterilization batch.We have set cleaning frequencies in the area, including machines, tools, and equipment, to ensure the cleanliness and quality of products.Before shipment, qc conducts outgoing inspections to check the overall condition of the products.The supplied cannula raw material is tpc inspected wherein the overall visual condition of the cannula has been checked.From the previous two fiscal years to the present, we received a total of six (6) complaints for the same issue.The cause of these complaints was not identified as being related to our product or the manufacturing process.The root cause of the complaint could not be linked to our product and production process.Our needles follow the requirements set on iso 7864 and iso 10993.Every lot is tested for the presence of bacterial endotoxin to ensure that our products are safe to use and will not cause any harm.We also have monthly physicochemical tests to check for metal and alkaline traces.Cleanliness is maintained inside the production area to ensure that the products are free from foreign material contamination.All finished products are sterilized using the electron beam sterilization process, and qc performs outgoing inspection prior to shipment to ensure the overall condition of the needles.Therefore, our process is assured.This report pertains to the second patient associated with adverse event report (aer) number 25572642.The corresponding mdr number for the first patient is provided in section h10.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
Terumo medical received information through the united states food and drug administration (fda) medwatch/drug quality reporting system (dqrs) regarding sublocade 100 mg, lot #9246109us, with an expiration date of 30 apr 2026.The report described an injection site reaction characterized as erythema.This was the second time the patient received a sublocade injection administered subcutaneously in the abdomen.The first injection did not result in any reaction.However, following the second injection, the patient experienced erythema at the injection site, described in the report as "almost like tick bite in appearance." the dose administered was 100 mg from lot #g246109us, and the injection was reported to have been administered properly.The report also noted that a second patient experienced the same reaction with the same lot number, and a separate file will be submitted for that case.Additional information was received on 14 aug 2025 indicating that the sample is not available for evaluation.Two reaction events have been reported.It has not been confirmed whether the patient is stable.Injection site reaction was noted.The injections were administered.Estimated blood loss is not applicable.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to correct section g4 (premarket identification) and update section h6 (type of investigation) with additional code.

• 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: 23023131
• Report Number: 3003902955-2025-00065
• Device Sequence Number: 9702072
• Product Code: FMI
• UDI-Device Identifier: 14806017510715
• UDI-Public: (01)14806017510715(17)280630(10)230722C
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: SG3+1916
• Device Catalogue Number: N/A
• Device Lot Number: 230722C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SUBLOCADE INJECTION 100MG
• Patient Sex: Unknown