BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T BNS

    MDR report key: 19176414 · Received April 24, 2024

    Report

    Report Number
    1213809-2024-00252
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 8, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010252
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ONE PHOTO OF A 1ML LUER-SLIP SYRINGE WAS RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE PHOTO FROM BATCH 3172356 REGARDING ITEM 301025. THE IMAGE SHOWS A PORTION OF ONE LOOSE SYRINGE OF THE BARREL TIP AREA THAT IS PARTIALLY FILLED WITH A CLEAR FLUID. NO DEFECT IS OBSERVED IN THE PHOTO PROVIDED. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTO RECEIVED. THEREFORE, CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3172356 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER 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.

    Description of Event or Problem · 0

    MATERIAL # UNKNOWN. LOT # 2373261. IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMALL BLACK SPOT ON TB SYRINGE." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. SMALL BLACK SPOT ON TB SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616698 BD SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3172356 50382903010252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown