BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 25115902 · Received May 7, 2026

    Report

    Report Number
    9681413-2026-00006
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    September 17, 2025
    Report Date
    May 7, 2026
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    UDI-DI
    05413206251223
    PMA / PMN Number
    K230951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    . 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, 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 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.

    Description of Event or Problem · 0

    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 17SEP2025, SHE REPORTED DECLINE IN VISION OUT WITH FLOATERS. WHEN SHE PRESENTED ON 15OCT2025, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192443 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2407010 05413206251223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SYRINGE (FOR PRODUCT VABYSMO)