BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 23839876 · Received December 18, 2025

    Report

    Report Number
    1911916-2025-00811
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 11, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052004
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (B) ADDED EVENT DETAILS. INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305200. BATCH #: 2172517. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ADVERSE EVENT, ENDOPHTHALMITIS. PATIENT EXPERIENCED AN ADVERSE EVENT POST INJECTION. NEEDLE LOT 2172517. NO DEVICE FAILURE NOTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: PER THE DSO (DRUG SAFETY OFFICER), THE PHYSICIAN REPORTED THAT PATIENTS WERE TREATED WITH STEROIDS AND SOME HE TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385809 BD NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 2172517 00382903052004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other