BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 21559221 · Received March 10, 2025

    Report

    Report Number
    1213809-2025-00177
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 18, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) - SUPPLEMENTAL MDR - STOPPER SEPARATION FROM PLUNGER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED

    Description of Event or Problem · 0

    MATERIAL: 301027. BATCH#: 4171418. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS STOPPER HAD SEPARATION FROM THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PAIN MANAGEMENT TRAY CONTAINED A 5 ML SYRINGE WITH A DEFECTIVE PLUNGER. GASKET CAME OFF THE TRACK OF THE PLUNGER WHEN TRYING TO EXTRACT MEDICATIONS FROM A VIAL. ITEM -301027. LOT - 4171418.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254368 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4171418 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown