BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 24866145 · Received April 13, 2026

    Report

    Report Number
    1213809-2026-00195
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 22, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 BD SYRINGE 5ML LL BNS CONTAINED FOREIGN MATTER. VERBATIM: COMPLAINT VIA EMAIL. I WANTED TO LET YOU KNOW THAT WE HAVE OPENED NCMR (B)(4) FOR ANOTHER BATCH OF RM10155. DURING INCOMING INSPECTION, STREAKS OF PARTICULATE WERE OBSERVED ON A FEW SYRINGE SAMPLES. PLEASE SEE THE ATTACHED PHOTO AND BATCH INFORMATION BELOW. I ALSO ATTACHED NOTIFICATION SCAR (B)(4). THERE ARE NO DELIVERABLES BUT PLEASE MAKE SURE THIS IS SHARED WITH THE PROPER PERSONNEL SO THIS ISSUE CAN BE LOOKED INTO. ADDITIONALLY, PLEASE REACH OUT TO THE MANUFACTURER AND LET US KNOW HOW WE CAN PROCEED WITH DISPOSITIONING THIS BATCH. LOT# 5230886 WAS RECEIVED ON 02-19-2026. IT WAS INSPECTED ON 03-11-2026 AND I CONFIRMED THE NONCONFORMANCE THE SAME DAY. THE BATCH WAS ENTERED INTO NCMR ON 03-12-2026. YES WE HAVE THE THREE NONCONFORMING SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186418 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5230886 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1