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	Unspecified Eye / Vision Problem (4471)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: establishment name: unknown e1: phone number: unknown e1: establishment address: unknown e3: occupation: device quality manager.The batch records for lot 2407010 (nf3013rbke05m) have been reviewed.The following tests are performed on the product during production: during in-process control in needle assembly, (b)(4) needles are visually inspected per shift for foreign matter.No abnormalities related to this complaint were reported during these inspections.During in-process control in packaging, (b)(4) needles are visually inspected twice per shift for foreign matter.No abnormalities related to this complaint were reported during these inspections.Furthermore, a final visual inspection was performed on (b)(4) 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 (b)(4) 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.Based on our investigation including a batch record review, 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.For information regarding the importer report for this event, please refer to section h10.
Event or Problem Description
Terumo received the following information: healthcare professional reported bilateral sterile endophthalmitis and vasculitis after vabysmo, pfs 6mg, (lotb7005b09, exp date: 30apr2026) intravitreal injection on (b)(6) 2025.Patient had been receiving this drug without incident for about nine months.In the weeks following (b)(6) 2025, she reported decline in vision out with floaters.When she presented on (b)(6) 2025, she had bilateral dense endophthalmitis.Vitrectomy with vitreous biopsy was performed on one eye with injection of broad-spectrum antibiotics.Intraoperative view showed vasculitis.Decline in vision in both eyes (ou) with floaters, bilateral dense endophthalmitis.Vitrectomy with vitreous biopsy was performed on one eye with injection of broad-spectrum antibiotics.Intraoperative view showed vasculitis.

• 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: 25115902
• Report Number: 9681413-2026-00006
• Device Sequence Number: 10232095
• Product Code: QYM
• UDI-Device Identifier: 05413206251223
• UDI-Public: 05413206251223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NF-3013RBKE05M
• Device Catalogue Number: NF-3013RBKE05M
• Device Lot Number: 2407010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: Male