BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL EURO 200 S/C

    MDR report key: 12125768 · Received July 6, 2021

    Report

    Report Number
    1213809-2021-00473
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THREE PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO SHOWED THE GRAPHIC SIDE OF THE 3ML SYRINGE PACKAGING REVEALING THE 3ML SYRINGE (P/N 309658) TO BE FROM BATCH #0133147. TWO PHOTOS WERE RECEIVED SHOWING THE SYRINGE SEALED IN ITS BLISTERPAK. A SMEARING OF FOREIGN MATTER SEEN ON THE PACKAGE INTERIOR AND SYRINGE EXTENDING FROM THE FLANGE TO JUST BELOW THE 3ML GRAD LINES. . THE FOREIGN MATTER APPEARED TO BE GREASE AND WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #0133147 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. 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

    IT WAS REPORTED THAT SYRINGE 3ML LL EURO 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS DIRT IN THE PRODUCT PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL EURO 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS DIRT IN THE PRODUCT PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021182 SYRINGE 3ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0133147 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1