BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 19029427 · Received April 2, 2024

    Report

    Report Number
    1213809-2024-00195
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 15, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    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

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

    Additional Manufacturer Narrative · 0

    PR (B)(4): FOLLOW UP MDR FOR DEVICE EVALUATION. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. THE REPORTED DEFECT WAS MANUFACTURED IN THE HOLDREGE PLANT WHICH NO LONGER MANUFACTURES THIS PRODUCT. THEREFORE, NO CORRECTIVE ACTIONS ARE REQUIRED FROM THE CANAAN MANUFACTURING PLANT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A BLACK PARTICLE WAS NOTICED IN THE SYRINGE ONCE NORMAL SALINE WAS DRAWN UP INTO THE SYRINGE BY THE RADIOLOGIST." VERBATIM#: WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#PC-240294 HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT. PRODUCT INFORMATION. PRODUCT CODE: 302995. PRODUCT DESCRIPTION: SYRINGE HYPO 10CC L/L BX/200 && P52. LOT/SERIAL #: 3354734. EXPIRY DATE: 2028-11-30. PROBLEM INFORMATION: A BLACK PARTICLE WAS NOTICED IN THE SYRINGE ONCE NORMAL SALINE WAS DRAWN UP INTO THE SYRINGE BY THE RADIOLOGIST. OCCURRENCES: 1 EACH. SAMPLE INFORMATION: INCIDENT SAMPLES: 0. REPRESENTATIVE SAMPLES: 0. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728159 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3354734 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown