BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 25102817 · Received May 6, 2026

    Report

    Report Number
    9681413-2026-00005
    Event Type
    Injury
    Date Received
    May 6, 2026
    Date of Event
    November 13, 2025
    Report Date
    May 6, 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

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: ESTABLISHMENT NAME: UNKNOWN. E1: PHONE NUMBER: UNKNOWN. E1: ESTABLISHMENT ADDRESS: UNKNOWN. 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 2412006 (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 500 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 CONFORM THE SPECIFICATION. THE LAL AND STERILIZATION CYCLE WERE EXECUTED ACCORDING TO SPECIFICATION AND NO OBSERVATIONS HAVE BEEN FOUND FOR THESE TESTS. RETENTION SAMPLES: ALL REMAINING SAMPLES (87 PIECES) WERE VISUALLY INSPECTED FOR FOREIGN MATTER BY (B)(6) ON (B)(6) 2026 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.

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THE PATIENT HAD A SERIOUS BLINDING ISSUE REGARDING THE VABYSMO PFS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80910 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2412006 05413206251223

    Patients

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