BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    MDR report key: 8966077 · Received September 5, 2019

    Report

    Report Number
    3003152976-2019-00602
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 10, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, A SMALL PARTICLES WAS OBSERVED INSIDE THE SYRINGE. USING MAGNIFICATION THE PARTICLE WAS IDENTIFIED TO BE POLYPROPYLENE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1904240, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. WE PERFORM INSPECTIONS AND CLEARLY DEFINED CLEANING PROCEDURES AFTER PRODUCTION OF EACH LOT. CONCLUSION: WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE PARTICLE LIKELY GENERATED DURING THE TRANSPORT OF PRODUCT WITHIN THE MANUFACTURING EQUIPMENT, ATTACHING TO THE PRODUCT AS SEEN IN THE DEVICE REPORTED. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THE EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AS PART OF ASEPTIC MANUFACTURING, TWO BD PLASTIPAK DISPOSABLE SYRINGES ATTRACTED ATTENTION WITH 20 ML LUER-LOCK, IN WHICH INSIDE ARE SMALL FOREIGN BODIES."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD PLASTIPAK¿ 20ML SYRINGE LUER-LOK¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "AS PART OF ASEPTIC MANUFACTURING, TWO BD PLASTIPAK DISPOSABLE SYRINGES ATTRACTED ATTENTION WITH 20 ML LUER-LOCK, IN WHICH INSIDE ARE SMALL FOREIGN BODIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761917 BD PLASTIPAK 20ML SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. 1904240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other