BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 20413394 · Received October 9, 2024

    Report

    Report Number
    1213809-2024-00694
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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 #: 309646 BATCH#: 4190243 IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. FINDING RUBBER SHAVINGS IN THE 5ML SYRINGES ADDITIONAL INFORMATION PROVIDED: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO, THESE WERE CAUGHT BEFORE USED ON PATIENT ¿ ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? (B)(6). ¿ ANY PICTURE OF THIS COMPLAINT? SEE BELOW ¿ DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? NO, IT WAS CAUGHT BEFORE IT WAS USED ON A PATIENT ¿ DID THE EVENT INVOLVE AN URGENT/LIFE THREATENING MEDICAL SITUATION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932891 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4190243 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown