BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER-LOK

    MDR report key: 8565167 · Received April 30, 2019

    Report

    Report Number
    3003152976-2019-00293
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 13, 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
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: MULTIPLE SAMPLES WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A YELLOW COLOR CAN BE OBSERVED ON THE BLISTER PACKS. PACKAGES WERE OPENED AND WE WERE ABLE TO VERIFY THE COLOR IS ONLY ON THE PLASTIC FILM, NO DEFECTS OBSERVED ON THE PAPER PORTION OF THE BLISTER PACKAGING. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1811241. RETAINED SAMPLES OF THE SAME LOT WERE INSPECTED, NOT FINDING ANY PRODUCT WITH THIS DEFECT. TESTING WAS PERFORMED IN ATTEMPTS TO RECREATE THIS ISSUE, ALL RESULTS WERE FOUND TO BE SATISFACTORY, NO YELLOW COLORING WAS OBSERVED. THE SAMPLES RECEIVED WERE TESTED TO ENSURE PRODUCT INTEGRITY, ALL PACKAGES TESTED WERE FOUND TO BE PROPERLY SEALED AND STERILITY RESULTS VERIFY THE PRODUCT REMAINS STERILE. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. THE FILM FOR THE REPORTED LOT IS PROVIDED BY A SUPPLIER WHOM WE HAVE NOTIFIED OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES' PLASTIC PACKAGING WAS STAINED YELLOW AND FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC PACKAGE STAINED YELLOW".

    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 300 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES' PLASTIC PACKAGING WAS STAINED YELLOW AND FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLASTIC PACKAGE STAINED YELLOW"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358634 BD PLASTIPAK SYRINGE LUER-LOK SYRINGE FMF BECTON DICKINSON, S.A. 1811241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other