BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 20987250 · Received December 20, 2024

    Report

    Report Number
    1213809-2024-00974
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 20, 2024
    Report Date
    February 11, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH PHOTOS SHOW ONE LOOSE SYRINGE WITH A BLACK LINE ON OR IN THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. IT CANNOT BE DETERMINED FROM THE PHOTO PROVIDED IF THE FOREIGN MATTER IS INSIDE OR OUTSIDE OF THE BARREL. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY SO, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4051417. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL: 301073. BATCH#: 4051417. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PARTICULATES, ARE BEING FOUND IN BARREL OF 3ML SYRINGE 5ML SYRINGE. I NEED CREDITS BECAUSE THEY FELT ALL TRAYS ARE COMPROMISED THAT THEY OPENED. PRODUCT NUMBER - 301073. LOT NUMBER - 4051417.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062770 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4051417 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown