BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISIONGLIDE

    MDR report key: 25318306 · Received May 28, 2026

    Report

    Report Number
    1911916-2026-00247
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 26, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051274
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DESCRIPTION: MATERIAL: 305127 BATCH: 5203335. HAD A POTENTIAL DEFECTIVE NEEDLE THAT BROKE INTO A PATIENT REQUIRING SURGERY FOR REMOVAL. PRODUCT INFO: BD MANUFACTURER, LOT # 5203335/PEOPLESOFT NUMBER 102227/REF # (B(4) EXPIRATION 07/31/2030, BD PRECISION GLIDE NEEDLE 25G X 1 1/2 " (0.5MM). ADDITIONAL INFORMATION: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THE NEEDLE WAS LODGED IN THE PATIENT WHICH THE PATIENT HAD TO UNDERGO SURGERY TO REMOVE. WHAT WAS THE PATIENT OUTCOME? THE PATIENT RECEIVED SURGERY AND WAS RELEASED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9609 PRECISIONGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5203335 00382903051274

    Patients

    Seq Age Sex Outcome Treatment
    1