BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 19868405 · Received July 30, 2024

    Report

    Report Number
    1213809-2024-00505
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 16, 2024
    Report Date
    September 4, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION/CORRECTION CORRECTION: FOLLOWING SUBMISSION OF INITIAL MDR, THE CUSTOMER INFORMATION WAS NOT CORRECTLY REPORTED. SECTION E UPDATED TO REFLECT CORRECT CUSTOMER ADDRESS. EVALUATION: ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND MORE THAN SIX ORANGE PARTICULATES WERE OBSERVED ON THE STOPPER. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4123361. 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

    MATERIALS#: 302995, BATCH#: 4123361. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 10ML STERILE SYRINGE HAS PARTICULATE MATTER INSIDE THE SYRINGE. SYRINGE WAS NOT USED AS STERILITY MAY HAVE BEEN COMPROMISED. LOT 4123361 EXP: 4/30/29. DATE OF INCIDENT: 7/16/2024. WE HAVE THE SYRINGE AVAILABLE TO BE MAILED FOR FURTHER INVESTIGATION, KINDLY ADVISE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533958 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4123361 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown