BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 12453302 · Received September 10, 2021

    Report

    Report Number
    3003152976-2021-00594
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 12, 2021
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-12. H6: INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLE BARREL APPEARS DAMAGED. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DO NOT SHOW ANY DEFECT. FURTHER TESTING WAS CONDUCTED, NO SIGN OF LEAKAGE OCCURRED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2012069, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. THE ROOT CAUSE FOR LEAKAGE CAN BE RELATED WITH THE HIT SEEN IN THE BARREL. WHEN THERE IS DAMAGE IN THE BARREL, THE PART CAN BE DEFORMED LEADING TO LEAKAGE. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGES 50ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 50 ML LUER LOK SYRINGE PRODUCT . THE PROPOFOL WAS LEAKING OUT OF THE BACK OF IT DURING A TIVA. THE LOT NUMBER IS 2012069."

    Additional Manufacturer Narrative · 1

    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 2 SYRINGES 50ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 50 ML LUER LOK SYRINGE PRODUCT . THE PROPOFOL WAS LEAKING OUT OF THE BACK OF IT DURING A TIVA. THE LOT NUMBER IS 2012069."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354214 SYRINGE 50ML LL PISTON SYRINGE FMF 2012069

    Patients

    Seq Age Sex Outcome Treatment
    1