BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO

    MDR report key: 22801212 · Received August 13, 2025

    Report

    Report Number
    9681413-2025-00004
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 13, 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

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE OR DATE OF BIRTH: BORN YEAR 1942. A4: WEIGHT: REQUESTED, NOT PROVIDED . A5: ETHNICITY: REQUESTED, NOT PROVIDED . A6: RACE: REQUESTED, NOT PROVIDED . D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED . E3: OCCUPATION: DEVICE QUALITY MANAGER. A BATCH RECORD REVIEW WAS CONDUCTED FOR LOT 2409001 (NF3013RBKE05M). DURING NEEDLE ASSEMBLY, 315 NEEDLES WERE VISUALLY INSPECTED PER SHIFT FOR FOREIGN MATTER. ONE NONCONFORMITY RELATED TO FOREIGN MATTER WAS IDENTIFIED. CORRECTIVE ACTIONS WERE IMPLEMENTED, INCLUDING VISUAL INSPECTION OF THE PRODUCTS AND ADDITIONAL CLEANING OF THE MACHINE. THIS NONCONFORMITY IS NOT CONSIDERED RELEVANT TO THE REPORTED COMPLAINT. DURING PACKAGING, 40 NEEDLES WERE VISUALLY INSPECTED TWICE PER SHIFT FOR FOREIGN MATTER. NO ABNORMALITIES RELATED TO THE COMPLAINT WERE REPORTED. A FINAL VISUAL INSPECTION WAS PERFORMED ON 1,500 PIECES, WITH NO ABNORMALITIES OBSERVED. AS PART OF THE FINAL INSPECTION, PARTICULATE MATTER TESTING WAS CONDUCTED ON 84 PIECES AND VISUAL INSPECTION ON 13 PIECES. ALL RESULTS CONFORMED TO SPECIFICATIONS. THE LIMULUS AMEBOCYTE LYSATE (LAL) TEST AND STERILIZATION CYCLE WERE EXECUTED ACCORDING TO SPECIFICATIONS, WITH NO OBSERVATIONS REPORTED. THE SAMPLE ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. RETENTION SAMPLES WERE VISUALLY INSPECTED FOR FOREIGN MATTER ON AUGUST 8, 2025, WITH NO DEFECTS IDENTIFIED. BASED ON THE BATCH RECORD REVIEW AND RETENTION SAMPLE INSPECTION, NO ROOT CAUSE RELATED TO THE PRODUCTION PROCESS WAS IDENTIFIED. NO CAUSAL RELATIONSHIP COULD BE ESTABLISHED. TREND AND DEVIATION REVIEWS REVEALED NO SIMILAR ACTIONS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO EUROPE N.V. (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE COMPLAINT INVOLVES FILTER NEEDLES CO-PACKED WITH VABYSMO. A PATIENT DEVELOPED A BACTERIAL EYE INFECTION FIVE DAYS AFTER RECEIVING THE MEDICATION. THE INFECTION REQUIRED SURGICAL TREATMENT AT AN OPHTHALMOLOGY CLINIC. THE REPORTING CLINIC INDICATED THAT THE INFECTION MAY HAVE BEEN ASSOCIATED WITH THE MEDICATION. THE CASE WAS FORWARDED FROM THE DRUG COMMISSION OF THE GERMAN MEDICAL ASSOCIATION (AMK) TO THE REGIONAL COUNCIL TÜBINGEN (RP TÜBINGEN). THE INFECTION OCCURRED FOLLOWING THE MOST RECENT INJECTION; THE PREVIOUS NINE INJECTIONS WERE WELL TOLERATED, INCLUDING TWO PRE-FILLED SYRINGES. THE FIRST INJECTION IN (B)(6) 2024 AND ONE OF THE PRE-FILLED SYRINGES WERE FROM DIFFERENT BATCHES. THE PATIENT WAS HOSPITALIZED FOR ONE WEEK FOLLOWING SURGICAL TREATMENT. THE PATIENT WAS BEING TREATED FOR WET MACULAR DEGENERATION. THE EVENT OCCURRED POST-TREATMENT. SURGICAL INTERVENTION WAS REQUIRED. THE FINAL PATIENT IMPACT WAS PARTIAL RECOVERY; IMPROVEMENT WAS NOTED, BUT FULL RECOVERY HAD NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557085 TERUMO OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2409001 05413206251223

    Patients

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