BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19355749 · Received May 20, 2024

    Report

    Report Number
    1213809-2024-00303
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    May 1, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    ONE PHOTO OF A 3 ML LL SYRINGE (P/N 309657) WAS RECEIVED AND EVALUATED. THE PHOTO PARTIALLY SHOWS ONE SECTION OF A LOOSE SYRINGE WITH AN UNKNOWN TRANSPARENT SUBSTANCE IN THE FLUID PATH AND WHAT APPEARS TO BE A LOOSE DARK-COLORED UNKNOWN MATTER. UNABLE TO IDENTIFY THE FOREIGN SUBSTANCE. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE AND IDENTIFY THE FOREIGN SUBSTANCE. 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. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    MATERIAL #: 309657 BATCH#: 3180007 IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTAMINATED WITH AN UNIDENTIFIABLE SUBSTANCE INSIDE OF A 3CC SYRINGE."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584419 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3180007 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown