BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LS NS

    MDR report key: 8739403 · Received June 27, 2019

    Report

    Report Number
    3003152976-2019-00424
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE SAMPLE AND ONE PHOTO WAS PROVIDED TO OUR QUALITY ENGINEER TEAM FOR EVALUATION. THROUGH VISUAL INSPECTION, A BROWN MATTER WAS OBSERVED ON THE PLUNGER NERVES AND THE THUMB PRESS OF THE PRODUCT. THE SPOTS WERE IDENTIFIED TO CONSIST OF BURNT POLYPROPYLENE PARTICLES THAT GENERATE DURING THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1902350, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. WHILE NO DIRECT ISSUE WAS IDENTIFIED, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO A FAILURE IN THE INJECTION MACHINE USED DURING THE MOLDING PROCESS, RESULTING IN THE PARTICLES EMBEDDING INTO THE PRODUCT AS SEEN IN THE DEVICE REPORTED. THIS IS CONSIDERED AN AESTHETIC ISSUE THAT WILL NOT AFFECT THE FUNCTIONALITY OF THE SYRINGE. MACHINES ARE RAN PRIOR TO PRODUCTION TO REMOVE ANY EXCESS PARTICLES AND ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON THE PLUNGER OF THE SYRINGE WITH A BD SYRINGE 20ML LS NS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PRESENCE OF CONTAMINATION ON THE PLUNGER OF THE SYRINGE (BROWN SPOTS ON THE MATERIAL).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON THE PLUNGER OF THE SYRINGE WITH A BD SYRINGE 20ML LS NS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PRESENCE OF CONTAMINATION ON THE PLUNGER OF THE SYRINGE (BROWN SPOTS ON THE MATERIAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536165 BD SYRINGE 20ML LS NS SYRINGE FMF BECTON DICKINSON, S.A. 1902350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other