BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19700805 · Received July 9, 2024

    Report

    Report Number
    19700805
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 1, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "SITUATION/BACKGROUND: IV ROOM TECHNICIAN WAS PREPARING A DOSE OF MEDICATION BY FIRST DRAWING UP 0.9% SODIUM CHLORIDE INJECTION, USP WITH A BD 50 ML SYRINGE. WHEN TRYING TO REMOVE A BUBBLE, SHE NOTICED A LINE ON THE TIP OF THE SYRINGE. SHE NOTIFIED THE PHARMACIST (AUTHOR). THE BD 50ML SYRINGE LUER-LOK(TM) TIP-EMBOUT BD LUER-LOK(TM) (B)(4); LOT 4080202 EXP: [REDACTED DATE]. ASSESSMENT/RECOMMENDATION: UPON CLOSER EXAMINATION, IT WAS DEEMED NOT A MARKING, BUT A PIECE OF HAIR. THE SYRINGE WAS SEQUESTERED WITH THE FLUID STILL IN THE SYRINGE, THE OUTER WRAPPER OF THE SYRINGE WAS ALSO SAVED. THE MOCS OF CH PHARMACY AND YSC/SRC WERE NOTIFIED. SYRINGES WITH THE SAME LOT NUMBER WERE REMOVED FROM THE IV ROOM AND CH PHARMACY SATELLITE AND SEQUESTERED AND LABELED "DO NOT USE". MOC WILL SUBMIT TO PRODUCT INQUIRY TEAM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250014 BD LUER-LOK SYRINGE, PISTON FMF BECTON, DICKINSON AND COMPANY 309653 4080202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown