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 Codes	Inflammation (1932); Uveitis (2122); Vitritis (2181)
Date of Event	11/17/2025
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 batch records for lot 2412011 (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.(b)(4) products were found with embedded dirt.(b)(4) in the hub and (b)(4) in the protector.This is a minor defect and was within the acceptance level.Since these products are sterilised and the particles are embedded, it is very unlikely that this would cause a patient reaction.As part of the final inspection, particulate matter is tested on (b)(4) 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.Sample investigation: not returned.Retention samples all remaining samples (b)(4) pieces were visually inspected for foreign matter by n.Eymael on 10/12/2025 by the naked eye.No defects were found.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.
Event or Problem Description
Terumo received the following reported information: the complaint affects filter needles co-packed with vabysmo.A doctor, from the spanish hospital, reported to our local aps department that he has concerns about the quality of vabysmo pfs.The doctor requests roche to investigate any potential product quality deficiencies that may have contributed to the adverse event.The doctor has not reported any specific product quality deficiency.The patient had vitritis, panuveitis and uveitis.The procedure outcome is unknown.

• 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: 23888159
• Report Number: 9681413-2025-00011
• Device Sequence Number: 20010149
• 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): 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): 12/24/2025

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: 2412011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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