BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18618279 · Received January 31, 2024

    Report

    Report Number
    1213809-2024-00048
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 10, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO OF 10ML TRAY PACKAGES LOT 3152766 WAS RECEIVED AND EVALUATED. THE IMAGE SHOWS THREE SEALED TRAY PACKAGES WITH ONLY THE LOT, UDI, AND EXPIRATION DATE INFORMATION ON ONE OF THE TRAY PACKAGES AND MISSING FROM THE TWO OTHERS. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE LABEL CONTENT MISSING DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3152766 SHOWING 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

    MATERIALS#: 309605, BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE BOXES TWO PACKS WITH NO LOT NUMBERS OR EXPIRY ON THEM. VERBATIM: THIS TIME I'M REACHING OUT TO YOU FOR A DIFFERENT MATTER REGARDING THE 10ML SYRINGE TRAY WITH PRODUCT CODE 309605. WE ORDER THIS PRODUCT FROM CARDINAL HEALTH IN LARGE QUANTITIES. IN THE MOST RECENT ORDER, WE FOUND IN ONE OF THE BOXES TWO PACKS WITH NO LOT NUMBERS OR EXPIRY ON THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK LABEL CONTENT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS TIME I'M REACHING OUT TO YOU FOR A DIFFERENT MATTER REGARDING THE 10ML SYRINGE TRAY WITH PRODUCT CODE 309605 . WE ORDER THIS PRODUCT FROM CARDINAL HEALTH IN LARGE QUANTITIES. IN THE MOST RECENT ORDER, WE FOUND IN ONE OF THE BOXES TWO PACKS WITH NO LOT NUMBERS OR EXPIRY ON THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261138 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152766 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown