BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 22168015 · Received June 9, 2025

    Report

    Report Number
    9681413-2025-00002
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 9, 2025
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    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

    D4: DI: (B)(4). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: DEVICE QUALITY MANAGER. 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 1500 PIECES. (B)(4) 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 THE SPECIFICATION. THE LAL FOR LOT 2410003 WAS EXECUTED ACCORDING TO SPECIFICATIONS AND NO OBSERVATIONS HAVE BEEN FOUND FOR THIS TEST. A NON-CONFORMITY WAS CREATED FOR THE STERILIZATION CYCLE IN WHICH LOT 2410003 WAS INCLUDED. THE CAUSE FOR THIS NON-CONFORMITY WAS THAT THE AERATION PHASE EXCEEDED THE SPECIFIED TIME. THIS HAS NO IMPACT ON THE STERILITY OF THE PRODUCT. RETENTION SAMPLES: ALL REMAINING RETENTION SAMPLES WERE VISUALLY INSPECTED FOR FOREIGN MATTER WITH THE NAKED EYE BY N. EYMAEL ON 04/06/2025. 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 CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. 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 WHILST BEING TREATED WITH VABYSMO PFS (6MG/0.05ML). THE EVENT OCCURRED POST-TREATMENT. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE PROCEDURE OUTCOME AND PATIENT IMPACT WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477011 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2410003

    Patients

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