BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 23888156 · Received December 24, 2025

    Report

    Report Number
    9681413-2025-00008
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    November 17, 2025
    Report Date
    December 24, 2025
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    UDI-DI
    05413206251223
    PMA / PMN Number
    K230951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: DEVICE QUALITY MANAGER. THE BATCH RECORDS FOR LOT 2412011 ((B)(4)) 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. TWO (2) PRODUCTS WERE FOUND WITH EMBEDDED DIRT, ONE IN THE HUB AND ONE IN THE PROTECTOR. THIS IS A MINOR DEFECT AND WAS WITHIN THE ACCEPTANCE LEVEL. SINCE THESE PRODUCTS ARE STERILISED AND THE PARTICLES ARE EMBEDDED, IT IS VERY UNLIKELY THAT THIS WOULD CAUSE A PATIENT REACTION. 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. SAMPLE INVESTIGATION: NOT RETURNED. RETENTION SAMPLES ALL REMAINING SAMPLES (87 PIECES) WERE VISUALLY INSPECTED FOR FOREIGN MATTER BY N. EYMAEL ON 10/12/2025 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 COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. A DOCTOR, FROM THE SPANISH HOSPITAL, REPORTED TO OUR LOCAL APS DEPARTMENT THAT HE HAS CONCERNS ABOUT THE QUALITY OF VABYSMO PFS. THE DOCTOR REQUESTS ROCHE TO INVESTIGATE ANY POTENTIAL PRODUCT QUALITY DEFICIENCIES THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE DOCTOR HAS NOT REPORTED ANY SPECIFIC PRODUCT QUALITY DEFICIENCY. THE PATIENT HAD VITRITIS AND IS RECOVERING/RESOLVING. THE PROCEDURE OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057077 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2412011 05413206251223

    Patients

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