BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL BNS

    MDR report key: 11115103 · Received January 5, 2021

    Report

    Report Number
    1213809-2020-00945
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 7, 2020
    Report Date
    December 31, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE PHOTO OF A LOOSE 5ML SYRINGE FILLED WITH APPROXIMATELY 3ML OF CLEAR FLUID WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A SMALL WHITE CYLINDRICAL FOREIGN MATTER PARTICLE PRESENT INSIDE THE FLUID PATH NEAR THE STOPPER. THE SYRINGE APPEARED TO BE MANIPULATED AND THE FOREIGN MATTER DEFECT COULD NOT BE CONFIRMED. 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. INVESTIGATION CONCLUSION: OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT COULD NOT BE CONFIRMED TO ORIGINATED FROM THE MANUFACTURING SITE. THE PRODUCT IS SOLD AS BULK NON-STERILE AND THE PHOTOS DISPLAY A MANIPULATED SYRINGE. RATIONALE: NO CAPA REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEAR SIR/MADAM I AM WRITING TO INFORM YOU OF A CONTAMINATED SYRINGE REPORTED BY A CUSTOMER, PRODUCT NO. 301027, FROM LOT NO. 8356762. COULD YOU PLEASE LOG INTERNALLY, BVI DO NOT REQUIRE AN INVESTIGATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15600 SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8356762

    Patients

    Seq Age Sex Outcome Treatment
    1