BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19226730 · Received May 1, 2024

    Report

    Report Number
    1213809-2024-00265
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 12, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TEN SAMPLES OF 3ML EUROGRAPHICS SYRINGES (P/N - 309658) WERE RECEIVED AND EVALUATED. ALL SAMPLES WERE RECEIVED LOOSE WITH SILICONE VISIBLE ON THE STOPPER. THERE WAS NO STRINGING OR POOLING, THEREFORE THE SILICONE OBSERVED IS NOT EXCESSIVE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM GERMAN TO ENGLISH: WE NOTICED A QUALITY DEFECT IN THE FOLLOWING DEVICE IN THE PHARMACY TODAY: BD PLASTIPAKTM 3 ML SYRINGE, LOT: 3122025, EXPIRY: 03.04.2028. WHEN THE PLUNGER IS MOVED, SILICONE OIL IS VISIBLY DEPOSITED ON THE INNER EDGE OF THE SYRINGE BODY. AS THIS WOULD LEAD TO PRODUCT CONTAMINATION, WE CANNOT USE THE SYRINGES AS THEY ARE. ARE YOU AWARE OF THIS PROBLEM? PLEASE GIVE US YOUR OPINION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857167 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3122025 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown