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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rn msn employee health & safety specialist.G4: pma/510(k): not available.The details of the sample's actual condition were unable to be determined 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 and collar.Sheath activation and component fit tests 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.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 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 short shot, 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 an incoming inspection which includes visual inspection, dimensional inspection, and verification of the quality certificate.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 six (6) complaints about the specific item code.The cause of these complaints was not identified as being related to our product or the manufacturing process.The retention samples were injected into the dummy arm veins and a rubber cork to simulate intravenous and intramuscular injections prior to safety activation.The safety sheath was successfully activated on the samples using three methods: finger, thumb, and hard surface activation.The needle did not bend, and no difficulties were encountered.The exact root cause could not be identified based on our investigation of all the available information regarding this issue.A review of the product's lot history file revealed no related issues that would prevent the safety sheath from activation.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
The user facility reported that an employee stated she had used her thumb to activate the safety device, and the needle bent during the attempt.The event occurred intra-operative.Additional information was received on 12 jun 2025: the staff member activated the needle using her thumb, and no needlestick injury occurred.Additional information was received on 13 jun 2025: the needle bending occurred after the medication was administered, the needle successfully delivered the medication, but the safety device was not successfully activated, and the needle was not correctly seated or safely secured by the device.The injection was intramuscular, but the exact site of administration (e.G., deltoid) is unknown.

• 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: 22470398
• Report Number: 3003902955-2025-00043
• Device Sequence Number: 8094378
• Product Code: FMI
• UDI-Device Identifier: 10612479246390
• UDI-Public: (01)10612479246390(17)290930(10)241023C
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/10/2025

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: 102-N251S3
• Device Catalogue Number: N/A
• Device Lot Number: 241023C
• 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: 06/10/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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: UNKNOWN MEDICATION.
• Patient Sex: Unknown