BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 18752200 · Received February 21, 2024

    Report

    Report Number
    3003152976-2024-00091
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 8, 2024
    Report Date
    June 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR ADDITIONAL INFORMATION AND DEVICE EVALUATION: ADDITIONAL INFORMATION: FOLLOWING SUBMISSION OF INITIAL MDR, LOT CODE WAS CLARIFIED BASED ON SAMPLES RETURNED AND UPDATED FROM UNKNOWN TO 2201026 IN SECTION D. TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL PACKAGING WAS INSPECTED AND NO DAMAGE OR DEFECTS WERE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF LOT 2201026. THREE RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCTS WERE INSPECTED, NO DAMAGE WAS FOUND TO THE DEVICE PACKAGING. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES, NO ISSUES RELATED TO THE REPORTED INCIDENT WAS IDENTIFIED. GIVEN THE SAMPLES DID NOT DISPLAY ANY ISSUES RELATED TO THE DEVICE PACKAGING, A ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    NUMEROUS SYRINGES HAVE DAMAGED PACKAGING.

    Description of Event or Problem · 0

    NUMEROUS SYRINGES HAVE DAMAGED PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58871 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2201026 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown