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

Model Number	N/A
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the complaint affects filter needles co-packed with vabysmo.On an unknown date, the patient developed endophthalmitis, suspected to be due to the transmission of an infectious agent via the medicinal product.The reporter assessed the suspected transmission of the infectious agent as related to vabysmo.The company also assessed the causality of endophthalmitis as related to vabysmo.The event occurred post-treatment.No medical or surgical intervention was required, and no harm was reported.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: requested, unknown.E1: establishment address: requested, unknown.E1: phone number: requested, unknown.E3: occupation: device quality manager.The actual sample was not returned.The batch records for lot 2408009 (nf3013rbke05m) have been reviewed.The following tests are performed on the product during production: (i) 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.(ii) 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.(iii) furthermore, a final visual inspection was performed on 1500 pieces.Two minor defects were found.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 sterilization and limulus amebocyte lysate (lal) tests for lot 2408009 were executed according to specifications, and no observations were found for these tests.All remaining retention samples were visually inspected for foreign matter with the naked eye on 25/03/2025, and 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.There has been no similar case reported.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.(b)(4).For information regarding the importer report for this event, please refer to section h10.

• 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: 22022808
• Report Number: 9681413-2025-00001
• Device Sequence Number: 8734034
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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 Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: NF-3013RBKE05M
• Device Lot Number: 2408009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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