BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21130777 · Received January 10, 2025

    Report

    Report Number
    1213809-2025-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 10, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR DEVICE EVALUATION AND CORRECTION. POST INVESTIGATION FINDINGS INDICATE AN ADDITIONAL FAILURE, "DAMAGE TO THE BARREL FLANGE AREA". IT WAS REPORTED THERE WAS A BLACK MARK AREA ON THE OUTSIDE SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO OF A 1ML LUER SLIP SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS ONE LOOSE SYRINGE WITH THE NEEDLE ATTACHED NEXT TO AN EYELEA BOX CARTON. THE SLIP TIP SYRINGE HAS DAMAGE TO THE BARREL FLANGE AREA AND AN EXCESSIVE SKEWED SCALE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE MARKING PROCESS. 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.

    Description of Event or Problem · 0

    MATERIAL #:309628 BATCH#:3131852 IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON (B)(6) 2024, THE FOLLOWING COMPLAINT WAS MADE KNOWN TO REGENERON BY HCP: "THE MEDICINE WAS FINE, BUT THE SYRINGE HAD A BLACK MARK AREA ON THE OUTSIDE SYRINGE." CATALOG #: 309628 LOT #: 3131852.

    Description of Event or Problem · 0

    POST INVESTIGATION FINDINGS INDICATE AN ADDITIONAL FAILURE, "DAMAGE TO THE BARREL FLANGE AREA".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566713 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown