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	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: medical assistant/practice administrator.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.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.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 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 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 three fiscal years to the present, we received a total of sixty-three (63) 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 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 that no related issues were encountered during the production of the reported lot.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.The occurrence of cannula pop up complaints specific to the 25-gauge surguard 3 hypodermic needle has increased in the fiscal year 2024.Tpc has initiated an in-depth investigation, led by the production engineering section, to confirm the product's design and determine the possible root cause of the needle bending out of the sheath during activation.(b)(4) (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 during use, the needles would bend.In one case, the health care provider (hcp) witnessed the needle bending to the side and through the protective sheath when activated against a hard surface.No needle stick occurred, and no patient or hcp injuries were reported.The needle was used for pediatric patient vaccines with prefilled vials or syringes that came with the vaccines, not terumo syringes.Additional information received on 27 mar 2025: the needles were not being used due to the bending issue during pediatric injections with frequently active patients.The product was put aside to prevent further incidents.No needle sticks occurred in any of the events, and no patient or health care provider (hcp) injuries were reported.

• 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: 21894811
• Report Number: 3003902955-2025-00021
• Device Sequence Number: 12858901
• Product Code: FMI
• UDI-Device Identifier: 10612479246390
• UDI-Public: (01)10612479246390(17)290228(10)240302C
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/23/2025

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: 240302C
• 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: 03/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2024
• 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