BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 9011707 · Received September 12, 2019

    Report

    Report Number
    3002682307-2019-00500
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    August 27, 2019
    Report Date
    October 14, 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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON INSPECTING THE SAMPLE, BROWN STAINS WERE OBSERVED IN THE BARREL. USING MAGNIFICATION THE PARTICLES WERE IDENTIFIED TO BE BURNT PARTICLES OF POLYPROPYLENE THAT WAS EMBEDDED FROM THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1904208, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. ALTHOUGH WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED DUE TO POLYPROPYLENE PARTICLES DETACHING FROM THE MOLD DURING THE INJECTION PROCESS AND BECOMING EMBEDDED WITHIN THE PRODUCT. INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE EXCESS MATERIALS AND WE PERFORM INSPECTIONS AND CLEARLY DEFINED CLEANING PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS FOREIGN MATTER OF DIRT INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRT INSIDE THE SYRINGE. THIS WAS NOTICED AFTER CUSTOMER EXTRACTED NACL INTO SYRINGE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS FOREIGN MATTER OF DIRT INSIDE THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIRT INSIDE THE SYRINGE. THIS WAS NOTICED AFTER CUSTOMER EXTRACTED NACL INTO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799431 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1904208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other