BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 18191358 · Received November 22, 2023

    Report

    Report Number
    1213809-2023-01330
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 25, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    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

    PR (B)(4)¿ FOLLOW UP MDR FOR DEVICE EVALUATION. THREE PHOTOS OF 3 ML SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS FROM LOT NUMBER 2223811 REGARDING MATERIAL NUMBER 301073. ONE IMAGE SHOWS A LOOSE SYRINGE WITH A LIGHT-COLORED HAIR-LIKE STRING SEVERAL INCHES LONG EXTENDING ALONG THE OUTSIDE OF THE SYRINGE. THE CONDITION OBSERVED CANNOT BE CONFIRMED TO HAVE ORIGINATED AT THE PACKAGING PLANT FROM THE PHOTO PROVIDED. ANOTHER PHOTO SHOWS A LOOSE SYRINGE WITH A BLUE PARTICULATE INSIDE THE FLUID PATH LARGER THAN LEVEL 4. ANOTHER PHOTO SHOWS A LOOSE SYRINGE DAMAGED APPEARING TO HAVE BEEN CRUSHED BETWEEN DIALS RENDERING UNUSABLE. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. THE PHOTO W/ THE BLUE PARTICULATE INSIDE IS APPLICABLE TO PR 9156015 POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FLUID PATH AND SYRINGE DAMAGED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2244043 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAIR (STRING FLASH) WAS FOUND ON TIP OF 3ML SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916870 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2223811 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown