BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSFER FILTER NEEDLE 18GX1 1/2"-5UM

    MDR report key: 19686682 · Received July 7, 2024

    Report

    Report Number
    1911916-2024-00464
    Event Type
    Injury
    Date Received
    July 7, 2024
    Date of Event
    June 18, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS NOTED THAT THIS EVENT IS A DUPLICATE OF EVENT REGISTERED UNDER BD REF# (B)(4). THIS MDR WILL BE VOID.

    Description of Event or Problem · 0

    DEFECT INFECTION: ¿PJP OPHTHALMOLOGY TOGETHER WITH MEDINFO INFORMED QA IN (B)(6) 2024, THAT AN EYE CLINIC IN SWEDEN HAVE HAD A CLUSTER OF PATIENTS (9 PATIENTS) WITH SIGN OF INFECTION (INTRAOCULAR INFLAMMATION) AFTER TREATMENT (PERFORMED DIFFERENT TIMES, DIFFERENT PATIENTS) WITH VABYSMO." NEITHER THE SAMPLE NOR ANY PHOTOGRAPHS ARE AVAILABLE. THIS IS A NOTIFICATION ONLY. NO INVESTIGATION IS CURRENTLY REQUESTED. PLEASE ACKNOWLEDGE THE RECEPTION OF THIS COMPLAINT.

    Description of Event or Problem · 0

    DUPLICATE OF EVENT REGISTERED UNDER BD REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979821 TRANSFER FILTER NEEDLE 18GX1 1/2"-5UM NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2363735 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O