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	Uveitis (2122)
Date of Event	01/13/2026
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.H6: investigation findings: code 3221 is based upon no sample returned; code 213 is based upon functional testing of the retention sample.H6 - investigation conclusion: code 4315 is based upon evaluation of user facility information and no device return; code 67 is based upon evaluation of the retention sample.The batch records for lot 2409011 (nf3013rbke05m) have been reviewed.No anomaly was found.The following tests are performed on the product during production: 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.During in-process control in packaging, 40 needles are visually inspected twice per shift for foreign matters.No abnormalities related to this complaint were reported during these inspections.Furthermore, a final visual inspection was performed on 1500 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 conforming to 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, no root cause related to our production process has been found.There is no out of trend found and there is no change in the benefit-risk determination.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 medical corporation received the following reported information: the patient received vabysmo injections in both eyes and subsequently developed bilateral uveitis in both eyes.The doctor had a lot of experience with this product, and it was the first time he encountered something like this.The pharmacist confirmed that the product used was stored at a temperature of 2-8°c.There were no temperature deviations.The final patient impact was 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: 24701780
• Report Number: 9681413-2026-00001
• Device Sequence Number: 18686149
• 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): 03/26/2026

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: 2409011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2024
• 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