BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 22022808 · Received May 14, 2025

    Report

    Report Number
    9681413-2025-00001
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 14, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: INITIAL REPORTER NAME: REQUESTED, UNKNOWN. E1: ESTABLISHMENT ADDRESS: REQUESTED, UNKNOWN. E1: PHONE NUMBER: REQUESTED, UNKNOWN . E3: OCCUPATION: DEVICE QUALITY MANAGER. THE ACTUAL SAMPLE WAS NOT RETURNED. THE BATCH RECORDS FOR LOT 2408009 (NF3013RBKE05M) HAVE BEEN REVIEWED. THE FOLLOWING TESTS ARE PERFORMED ON THE PRODUCT DURING PRODUCTION: (I) 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. (II) DURING IN-PROCESS CONTROL IN PACKAGING, 40 NEEDLES ARE VISUALLY INSPECTED TWICE PER SHIFT FOR FOREIGN MATTERS. NO ABNORMALITIES RELATED TO THIS COMPLAINT WERE REPORTED DURING THESE INSPECTIONS. (III) FURTHERMORE, A FINAL VISUAL INSPECTION WAS PERFORMED ON 1500 PIECES. TWO MINOR DEFECTS WERE FOUND. AS PART OF THE FINAL INSPECTION, PARTICULATE MATTER IS TESTED ON 84 PIECES AND A VISUAL INSPECTION ON 13 PIECES. THIS WAS CONFORMING TO THE SPECIFICATION. THE STERILIZATION AND LIMULUS AMEBOCYTE LYSATE (LAL) TESTS FOR LOT 2408009 WERE EXECUTED ACCORDING TO SPECIFICATIONS, AND NO OBSERVATIONS WERE FOUND FOR THESE TESTS. ALL REMAINING RETENTION SAMPLES WERE VISUALLY INSPECTED FOR FOREIGN MATTER WITH THE NAKED EYE ON 25/03/2025, AND 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. THERE HAS BEEN NO SIMILAR CASE REPORTED. 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). FOR INFORMATION REGARDING THE IMPORTER REPORT FOR THIS EVENT, PLEASE REFER TO SECTION H10.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED ENDOPHTHALMITIS, SUSPECTED TO BE DUE TO THE TRANSMISSION OF AN INFECTIOUS AGENT VIA THE MEDICINAL PRODUCT. THE REPORTER ASSESSED THE SUSPECTED TRANSMISSION OF THE INFECTIOUS AGENT AS RELATED TO VABYSMO. THE COMPANY ALSO ASSESSED THE CAUSALITY OF ENDOPHTHALMITIS AS RELATED TO VABYSMO. THE EVENT OCCURRED POST-TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328705 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V N/A 2408009 05413206251223

    Patients

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