BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL BNS

    MDR report key: 23663037 · Received November 26, 2025

    Report

    Report Number
    1911916-2025-00770
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    September 30, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010332
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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

    E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. 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 THE BD SYRINGE 30ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 301033, BATCH # 5051686. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. MEDLINE COMPLAINT #: (B)(4), DEFECT DESCRIPTION: STAIN ON SYRINGE, MEDLINE PART #: 33239, PRODUCT DESCRIPTION: SYR 30ML L/L, VENDOR PART #: 301033, LOT #: 5051686, DATE REPORTED: 10/6/2025, SAMPLE RECEIVED: NO, RESPONSE NEEDED: ACKNOWLEDGMENT ONLY. CUSTOMER RESPONSE RECEIVED ON 12-NOV-2025: HELLO, THE STAIN WAS EMBEDDED WITHIN THE SYRINGE. THE CUSTOMER REPORTED THAT IT WOULD NOT SCRAPE OFF FROM THE INSIDE OR OUTSIDE. THE EVENT DATE IS 30-09-2025

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890705 BD SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5051686 00382903010332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown