BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL 120/PKG

    MDR report key: 11860619 · Received May 20, 2021

    Report

    Report Number
    3003152976-2021-00275
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BROWN SUBSTANCE WAS OBSERVED OVER THE PLUNGER OF THE SYRINGE. FURTHER EVALUATION IDENTIFIED THE SUBSTANCE TO BE GREASE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010027, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. ALTHOUGH NO DIRECT ISSUES WERE IDENTIFIED AND PRODUCTION AND INSPECTION RECORDS HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE PROPERLY PERFORMED, THE GREASE LIKELY ACCUMULATED IN THE PLUNGER MOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML LL 120/PKG HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION EVIDENT IN UNOPENED 10 ML SYRINGE - MOST LIKELY SILICONE.

    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 SYRINGE 20ML LL 120/PKG HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION EVIDENT IN UNOPENED 10 ML SYRINGE - MOST LIKELY SILICONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750220 SYRINGE 20ML LL 120/PKG SYRINGE FMF BECTON DICKINSON, S.A. 2010027

    Patients

    Seq Age Sex Outcome Treatment
    1