BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18016615 · Received October 26, 2023

    Report

    Report Number
    1213809-2023-01180
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 5, 2023
    Report Date
    March 5, 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

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO OF A 10 ML SYRINGE WAS RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO FROM AN UNKNOWN LOT NUMBER REGARDING MATERIAL NUMBER 309605. THE IMAGE SHOWS A LOOSE SYRINGE IN AN UNKNOWN BAG FILLED WITH A CLEAR UNKNOWN FLUID WITH A STICKER AFFIXED TO THE NON-SCALE MARKING SIDE; HOWEVER, SOME OF THE STICKER IS NOT FULLY AFFIXED TO THE BARREL AND IS HANGING OFF. THE REPORTED DEFECT CANNOT BE CONFIRMED FROM THE PHOTO PROVIDED. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. THE REPORTED DEFECT CANNOT BE CONFIRMED FROM THE PHOTO PROVIDED. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3114363 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBERS INCLUDE 3130638 AND 3123961. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGES HAD PEELING LABELS, LABEL CONTENT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAVING ISSUES WITH THE LABELS PEELING OFF THE 5 ML SYRINGES. I UNFORTUNATELY DO NOT HAVE ANY EXAMPLES OF THE 5 ML TO SHOW YOU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700942 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3114363 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown