BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 22823815 · Received August 16, 2025

    Report

    Report Number
    1911916-2025-00587
    Event Type
    Injury
    Date Received
    August 16, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 4, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    IT IS REPORTED ENDOPHTHALMITIS. EVENT DESCRIPTION: MATERIAL # 305106. BATCH # 4060059, 4031552. MY NAME IS (B)(6), I'M A RETINAL TECHNICIAN, AND I'M SENDING THIS MESSAGE ON BEHALF OF (B)(6) AND IN REGARD TO THE 30G X 1/2 (0.3MM X 13MM) NEEDLES (REF - (B)(4)). OVER THE PAST MONTH WE'VE SEEN AN INCREASE IN OUR ENDOPHTHALMITIS RATE (THIS HAS BEEN IRRESPECTIVE OF CLINICIAN OR DRUG BEING GIVEN). SINCE THIS WAVE OF INFECTIONS, WE HAVE CHANGED ALL THE VARIABLES ON OUR END THAT WERE ABLE TO (I.E. THE MANNER IN WHICH WE NUMB PATIENTS, DISCARDING NUMBING DROPS, ETC). THE ONLY COMMON DENOMINATOR AMONGST ALL OF THESE INSTANCES IS THE BRAND OF AND LOT #S OF THE NEEDLES THAT HAS BEEN USED (LOT S 4060059 AND 4031552). WE'VE BEEN MONITORING THE (B)(6) WEBSITE AS WELL THE BD WEBSITE OF ALL RECALLS AND WE HAVEN'T SEEN ANY RECENT RECALLS WITH THESE SPECIFIC LOTS (4060059 AND 4031552). WE'RE INQUIRING TO SEE IF THERE MAY HAVE BEEN OTHER CLINICS REPORTING AN INCREASE IN THEIR ENDOPHTHALMITIS RATE AND ASSOCIATED WITH THE USE OF THESE SPECIFIC LOTS OF 30G NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546457 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060059 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other