MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL); SYRINGE, ANTISTICK

Model Number	102-SNT1C2705S3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when using the safety feature, the needle broke in half.The event occurred intra-operative.
Additional Manufacturer Narrative
E3: occupation: requested, unknown.The actual condition of the sample was not able to be determined as it was not available for evaluation.Retention samples were visually inspected and found to be free of any damage, bent needles, or irregularities on the sheath and collar.Sheath activation was performed on the samples, and all passed.There was no issued nonconformity report related to human error during lot production.The supplied assembled needles were manufactured at needle assembly machine 8.The machine has an inspection system that detects tilted and bent cannulas.Dummy checking is conducted every type change, end of the lot, 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.The safety sheath is activated with a one-handed operation by pressing the sheath either by finger, thumb, and surface activation.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 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 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 a warning not to use bent or damaged needles.Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage.It has undergone incoming inspection which includes visual inspection, dimensional inspection, and verification of quality certificate.From the previous two fiscal years to the present, we received a total of fourteen (14) complaints for the same issue, the cause of which was not identified as being related to our product or the manufacturing process.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 no related issues that would cause the needle to break 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 perform an outgoing inspection prior to shipment to ensure the overall condition of the needles.Our process is assured, and the complaint is unrelated to our manufacturing process.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.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL)
• Common Device Name: SYRINGE, ANTISTICK
• 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: 20591355
• Report Number: 3003902955-2024-00063
• Device Sequence Number: 6567844
• Product Code: MEG
• UDI-Device Identifier: 10612479246611
• UDI-Public: 10612479246611
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113422
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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-SNT1C2705S3
• Device Lot Number: 231120D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2023
• 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: PRE-FILLED VACCINE SYRINGE
• Patient Sex: Unknown