BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 23X1 RB

    MDR report key: 24027267 · Received January 9, 2026

    Report

    Report Number
    1911916-2026-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 13, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051458
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 23X1 WAS CONTAMINATED WITH FOREIGN MATTER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT DESCRIPTION: NEEDLE DISPOSABLE HSI ITEM NUMBER: 9870934. MANUFACTURER PART NUMBER: 305145 LOT OR SERIAL NUMBER: LOT NUMBER EXPIRY DATE 5064152 04/30/2030. ISSUE: CLIENT REPORTS A "HARD,WHITE SUBSTANCE" ACCUMULATED ON OUTER SURFACE OF NEEDLES,IS RETICENT TO USE-- NO ADVERSE EVENT(S) REPORTED-- (B)(4) 12/15/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90501 BD NEEDLE 23X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5064152 00382903051458

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other