BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 24090311 · Received January 15, 2026

    Report

    Report Number
    9681413-2025-00013
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    December 4, 2025
    Report Date
    January 15, 2026
    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 ACTUAL DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO.( B)(4) SUBMITTING THIS REPORT ON BEHALF OF TERUMO EUROPE N.V. (MANUFACTURER) REGISTRATION NO. 9681413.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. BATCH RECORD REVIEW: THE BATCH RECORDS FOR LOT 2412006 (NF3013RBKE05M) HAVE BEEN REVIEWED. THE FOLLOWING TESTS ARE PERFORMED ON THE PRODUCT DURING PRODUCTION: 1) 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. 2) 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. 3) 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. SAMPLE INVESTIGATION: RETENTION SAMPLES ALL REMAINING SAMPLES (87 PIECES) WERE VISUALLY INSPECTED FOR FOREIGN MATTERL BY THE NAKED EYE. NO DEFECTS WERE FOUND. COMPLAINT SAMPLE: NO COMPLAINT SAMPLE WAS RECEIVED, SO NO INVESTIGATION COULD BE PERFORMED. CONCLUSION: 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 MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. CIOMS FORM RECEIVED FROM ROCHE GLOBAL WITH RELATED CAUSALITIES: BLIND; SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA MEDICINAL PRODUCT. THE PROCEDURE OUTCOME AND FINAL PATIENT IMPACT ARE BOTH UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 07JAN2026: IT CONCERNS A PATIENT OF UNKNOWN DEMOGRAPHICS (HEIGHT, WEIGHT AND PATIENT NUMBER NOT REPORTED (B)(6) WHO DEVELOPED SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT AND BECAME BLIND IN BOTH EYES (BILATERAL BLINDNESS) WHILST PARTICIPATED IN NIP-US-1400, ACCESS SOLUTIONS WHILE BEING TREATED WITH FARICIMAB (VABYSMO). NO MEDICAL HISTORY, PAST PRODUCTS, CONCURRENT CONDITIONS OR CONCOMITANT PRODUCTS WERE REPORTED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH INTRAVITREAL SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE FARICIMAB 6 MG FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT AND BECAME BLIND IN BOTH EYES (BILATERAL BLINDNESS) AFTER THE 2ND BILATERAL EYE TREATMENT WITH VABYSMO PREFILLED SYRINGE IN THE HCP SETTING. THE STATUS OF THERAPY WITH FARICIMAB WAS NOT REPORTED IN RESPONSE TO BLIND AND AFTER THE 2ND BILATERAL EYE TREATMENT WITH VABYSMO PREFILLED SYRINGE 6 MG DOSE IN THE HCP SETTING, THE PATIENT WENT BLIND IN BOTH EYES (BILATERAL BLINDNESS). AT THE TIME OF REPORT THE OUTCOME OF BLIND AND SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT WAS UNKNOWN. THE OUTCOME OF THE AFTER THE 2ND BILATERAL EYE TREATMENT WITH VABYSMO PREFILLED SYRINGE 6 MG DOSE IN THE HCP SETTING, THE PATIENT WENT BLIND IN BOTH EYES (BILATERAL BLINDNESS) WAS NOT REPORTED. THE REPORTER DID NOT REPORT THE CAUSALITY OF BLIND AND AFTER THE 2ND BILATERAL EYE TREATMENT WITH VABYSMO PREFILLED SYRINGE 6 MG DOSE IN THE HCP SETTING, THE PATIENT WENT BLIND IN BOTH EYES (BILATERAL BLINDNESS) WITH FARICIMAB WHILE SUSPECTED TRANSMISSION OF INFECTIOUS AGENTS VIA A MEDICINAL PRODUCT WAS ASSESSED AS RELATED WITH FARICIMAB. NO OTHER CAUSAL RELATIONSHIPS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151317 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)