BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 23309560 · Received October 16, 2025

    Report

    Report Number
    2243072-2025-01256
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 20, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP ONE PHOTO OF A 3 ML LUER-LOK SYRINGE (PART NUMBER 309581, BATCH 4221231) WAS RECEIVED AND EVALUATED. THE PHOTO SHOWS THE TOP WEB SLIP WITH ALL APPROPRIATE PRODUCT INFORMATION, AND NO DEFECTS WERE OBSERVED. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBER 4221231, WHICH SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. 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

    1. (B)(6) 2025 2. 4221231 3. PATIENT OPENED PACKAGING FOR UNUSED NEEDLE AND SYRINGE AND OBSERVED A SMALL AMOUNT OF FLUID/LIQUID PRIOR TO ADMINISTERING HER B-12. SINCE SHE OBSERVED THIS PRIOR TO DRAWING UP HER MEDICATION, SHE SAVED IT ASIDE AND DID NOT USE IT, THEREFORE CLASSIFYING THIS AS A NEAR MISS EVENT EVEN THOUGH IT DID REACH THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED HELLO, I AM NEEDING TO FILE A REPORT OF A CONTAMINATED SYRINGE. WE PURCHASE BD PRODUCTS THROUGH OUR WHOLESALER, NOT DIRECTLY FROM BD, BUT WHEN I REGISTERED FOR AN ACCOUNT, IT WAS DENIED. I DO NOT HAVE A PREFERENCE OF HOW TO FORMALLY NOTIFY BD OF THIS ISSUE, BUT ON BEHALF OF THE PATIENT, I WANTED TO BE SURE IT GETS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098519 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown