BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISIONGLIDE

    MDR report key: 25243475 · Received May 21, 2026

    Report

    Report Number
    1911916-2026-00232
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT IS REPORTED, NEEDLE 18X1 RB, FOREIGN MATTER. CUSTOMERS RN WAS WORKING AS A BOARDER NURSE IN THE EMERGENCY ROOM. AFTER DRAWING UP SOLUMEDROL FOR A PATIENT, SHE NOTICED A FOREIGN BODY IN THE BD 3 ML SYRINGE. THERE WAS WHAT APPEARS TO BE THE METAL PORTION OF A SMALL GAUGE, 1-INCH HYPODERMIC NEEDLE IN THE SYRINGE WITH THE MEDICATION. THE DRAW WAS MADE WITH A 3 ML BD SYRINGE USING A BD PRECISIONGLIDE NEEDLE, 18 GA 1 INCH, LOT NUMBER 6020565. IT IS EXTREMELY UNLIKELY THE SMALLER NEEDLE COULD HAVE COME OUT OF THE SOLUMEDROL VIAL AND IMPOSSIBLE THAT IT WAS ALREADY IN THE BD SYRINGE. ELIMINATING THOSE AS SUSPECTS, THE NEEDLE HAD TO BE INSIDE THE LUMEN OF THE BD PRECISIONGLIDE 18 GA 1 INCH NEEDLE, PROBABLY FROM THE MANUFACTURING PROCESS. I HAVE THE SYRINGE AND NEEDLE; WE LEFT IT AS IT WAS WHEN DISPENSED. I ALSO HAVE THE PACKAGING FOR THE NEEDLE INVOLVED. ALSO OF NOTE, THE PRECISIONGLIDE NEEDLE, 18 GA 1 ½ INCH NEEDLES CAN HAVE THE SAME LOT NUMBER AS THE 1 INCH. THIS OCCURRED IN THE MEDICATION ROOM AND DID NOT REACH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276509 PRECISIONGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6020565 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1