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	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not available.Instead, a reference photo was received.The sheath for the sg3 needle is activated, but the needle is bent out of it.Retention samples were visually inspected and found to be free of any damage, bent needles, tilted cannula, or irregularities on the sheath and collar.There was no issued nonconformity report related to human error during lot production.The needles were manufactured at needle assembly machines 1 and 8.Machine 8 has an inspection system that detects tilted and bent cannulas.Dummy checking is conducted for every type of change, end of the lot, and machine adjustment/troubleshooting/replacement of parts to ensure the accuracy of the inspection system.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.At the cannula station, an inspector ensures proper cannula alignment to prevent bent needles.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 in 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) provides detailed instructions for using the sg3 safety needle device, including warnings and precautions.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.It undergo incoming inspection which includes visual inspection, dimensional inspection, and verification of 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 facial years to the present, were received a total of (b)(4) complaints for 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'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, 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.The root cause of the problem based could not be identified on our investigation of all the available information about this issue.A review of the product's lot history file revealed no related issues that would cause the needle to bend during sheath 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 include cautions, precautions, and warnings to avoid problems during sheath activation.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the safety needles bend after administration.Additional information was received on 19 dec 2024: the needle stick injury is connected to the bent needle, as the accident occurred due to the bending of the needle.No information is available about whether the patient who received the injection was infected with hiv, hepatitis b, or another infectious disease.Due to private data, it is not possible to determine if the user was infected after the needle stick.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 but is designated as follow-up no.2 to correct the mfr report number submitted on february 06, 2025, which contained an incorrect mfr report number (3013394970-2024-00107f).The correct mfr report number should have been 3003902955-2024-00107f.All other information remains unchanged.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; no. 124 east main ave; laguna technopark; binan, laguna 4024 ; RP 4024
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; no. 124 east main ave; laguna technopark; binan, laguna 4024 ; RP 4024
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21130374
• Report Number: 3003902955-2024-00107
• Device Sequence Number: 6829883
• Product Code: FMI
• UDI-Device Identifier: 14806017509252
• UDI-Public: (01)14806017509252(17)290131(10)240216D
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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+2525
• Device Lot Number: 240216D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• 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
• Patient Sex: Unknown