BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19198288 · Received April 26, 2024

    Report

    Report Number
    1213809-2024-00261
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    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

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE UNNECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLUNGER FELL OUT OF SYRINGE WHILE PHLEBOTOMY WAS BEING PERFORMED." IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER FELL OUT OF SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE PLUNGER FELL OUT OF SYRINGE WHILE PHLEBOTOMY WAS BEING PERFORMED. ITEM#309646. LOT#4045835.

    Description of Event or Problem · 0

    MATERIAL# UNKNOWN BATCH# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE PLUNGER FELL OUT OF SYRINGE VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE PLUNGER FELL OUT OF SYRINGE WHILE PHLEBOTOMY WAS BEING PERFORMED. ITEM#309646. LOT#4045835.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870861 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4045835 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown