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.

• 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
• MDR Report Key: 22023062
• Report Number: 2243441-2025-00024
• Device Sequence Number: 9483577
• Product Code: QYM
• UDI-Device Identifier: 05413206251223
• UDI-Public: 05413206251223
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• 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
• Distributor Facility Aware Date: 04/24/2025
• Device Age: 8 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE (FOR PRODUCT VABYSMO).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown