BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20501019 · Received October 21, 2024

    Report

    Report Number
    1213809-2024-00747
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    October 4, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS ONE LOOSE SYRINGE WITH THE SCALE MARKINGS LIGHT AND MISSING ON THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCALE MARKINGS MISSING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. 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 4152592. 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#: 301027, BATCH#: 4152592. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAS A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. OUR PRODUCTION DEPARTMENT HAS DETECTED A SYRINGE WHERE THE PRINT IS MISSING OR ILLEGIBLE. THIS INFORMATION IS BEING SENT TO YOU AS AN AWARENESS EFFORT ONLY. UNFORTUNATELY, THE SYRINGE WAS DISCARDED AT OUR FACILITY AND IS UNAVAILABLE TO SEND TO YOU TO REVIEW. WE WERE ABLE TO OBTAIN A PHOTO OF THE SYRINGE BEFORE IT WAS DISCARDED (SEE BELOW). PLEASE FEE FREE TO CONTACT ME IF YOU HAVE ANY QUESTIONS. CPN 14858 ¿ YOUR PART#: 301027. YOUR LOT#: 4152592. PO: (B)(4). ADDITIONAL INFORMATION PROVIDED: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 04OCT2024. 3. TOTAL NUMBER OF OCCURRENCES? 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300895 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4152592 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown