MAUDE Adverse Event Report: TERUMO EUROPE N.V TERUMO INJECTION FILTER NEEDLE; OPHTHALMIC NEEDLE

Model Number	NF-3013RBKE05M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Vision (2139)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: device quality manager the actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.( b)(4) submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.9681413.
Event or Problem Description
Terumo medical corporation received the reported information.The complaint affects filter needles co-packed with vabysmo.Cioms form received from roche global with related causalities: blind; suspected transmission of infectious agents via medicinal product.The procedure outcome and final patient impact are both unknown.Additional information was received on 07jan2026: it concerns a patient of unknown demographics (height, weight and patient number not reported (b)(6) who developed suspected transmission of infectious agents via a medicinal product and became blind in both eyes (bilateral blindness) whilst participated in nip-us-1400, access solutions while being treated with faricimab (vabysmo).No medical history, past products, concurrent conditions or concomitant products were reported.On an unknown date, the patient started therapy with intravitreal solution for injection in pre-filled syringe faricimab 6 mg for an unknown indication.On an unknown date, the patient developed suspected transmission of infectious agents via a medicinal product and became blind in both eyes (bilateral blindness) after the 2nd bilateral eye treatment with vabysmo prefilled syringe in the hcp setting.The status of therapy with faricimab was not reported in response to blind and after the 2nd bilateral eye treatment with vabysmo prefilled syringe 6 mg dose in the hcp setting, the patient went blind in both eyes (bilateral blindness).At the time of report the outcome of blind and suspected transmission of infectious agents via a medicinal product was unknown.The outcome of the after the 2nd bilateral eye treatment with vabysmo prefilled syringe 6 mg dose in the hcp setting, the patient went blind in both eyes (bilateral blindness) was not reported.The reporter did not report the causality of blind and after the 2nd bilateral eye treatment with vabysmo prefilled syringe 6 mg dose in the hcp setting, the patient went blind in both eyes (bilateral blindness) with faricimab while suspected transmission of infectious agents via a medicinal product was assessed as related with faricimab.No other causal relationships were reported.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Batch record review: the batch records for lot 2412006 (nf3013rbke05m) have been reviewed.The following tests are performed on the product during production: 1) during in-process control in needle assembly, 315 needles are visually inspected per shift for foreign matter.No abnormalities related to this complaint were reported during these inspections.2) during in-process control in packaging, 40 needles are visually inspected twice per shift for foreign matter.No abnormalities related to this complaint were reported during these inspections.3) furthermore, a final visual inspection was performed on 500 pieces.No abnormalities related to this complaint were reported during these inspections.As part of the final inspection, particulate matter is tested on 84 pieces and a visual inspection on 13 pieces.This was conform the specification.The lal and sterilization cycle were executed according to specification and no observations have been found for these tests.Sample investigation: retention samples all remaining samples (87 pieces) were visually inspected for foreign matterl by the naked eye.No defects were found.Complaint sample: no complaint sample was received, so no investigation could be performed.Conclusion: based on our investigation including a batch record review and retention sample investigation, no root cause related to our production process has been found.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.9681413.

• Brand Name: TERUMO INJECTION FILTER NEEDLE
• Common Device Name: OPHTHALMIC NEEDLE
• Manufacturer (Section D): TERUMO EUROPE N.V; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer (Section G): TERUMO EUROPE N.V.; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 24090311
• Report Number: 9681413-2025-00013
• Device Sequence Number: 21384941
• Product Code: QYM
• UDI-Device Identifier: 05413206251223
• UDI-Public: 05413206251223
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K230951
• 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): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NF-3013RBKE05M
• Device Catalogue Number: NF-3013RBKE05M
• Device Lot Number: 2412006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: SYRINGE (FOR PRODUCT VABYSMO)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown