BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE

    MDR report key: 23596423 · Received November 19, 2025

    Report

    Report Number
    1911916-2025-00750
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    July 28, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THAT UPON REMOVING THE INJECTION NEEDLE CAP, THE MEDICATION BEGAN DISPENSING AUTOMATICALLY. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW BY THE QUALITY TEAM. THE FIRST IMAGE SHOWS A NEEDLE ASSEMBLED TO A SYRINGE, FOCUSING ON THE CONNECTION BETWEEN THE NEEDLE HUB AND THE SYRINGE LUER LOCK. THE SECOND IMAGE DEPICTS A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD IN PLACE. NO ADDITIONAL INFORMATION COULD BE OBTAINED FROM THESE PHOTOGRAPHS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 305106, LOT 4081033. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE DETECTED DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND THE PHOTOGRAPHIC ANALYSIS, THE REPORTED SYMPTOM COULD NOT BE CONFIRMED. WITHOUT THE PHYSICAL SAMPLE FOR EVALUATION, IT WAS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    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

    IT WAS REPORTED THAT THE BD NEEDLE 30X1/2 RB HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. MATERIAL: 305106, BATCH#: 4081033. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER: (B)(4). COMPLAINT DESCRIPTION: ON 30JUL2025 XX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE ¿ DEFECTIVE SYRINGE . ON 28JUL2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿WHEN THE DOCTOR ATTEMPTED TO REMOVE THE INJECTION NEEDLE CAP, IT AUTOMATICALLY STARTED "SHOOTING OUT (THE MEDICATION)" WITHOUT PRESSING THE PLUNGER.¿ LOT: 8463800035 INJECTION NEEDLE, CATALOG: 305106, LOT: 4081033. INVESTIGATIONAL REQUEST /RETURN COMPONENT STATUS PLEASE PERFORM AN EVALUATION OF THE PROCESS AND SAMPLE TO DETERMINE ANY POTENTIAL CONTRIBUTING FACTORS TO THE NEEDLE BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628305 BD PRECISIONGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 4081033 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown