BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8898903 · Received August 15, 2019

    Report

    Report Number
    9610847-2019-00517
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9060739. OUR RECORDS SHOW THAT THIS IS THE SECOND INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. COMPOSITION TESTING OF THE FOREIGN MATERIAL DETERMINED THAT THE SAMPLE TRAYS CONTAINED CARDBOARD DEBRIS, WHICH ORIGINATES FROM THE SYRINGE COMPONENT BOXES. THE COMPONENTS ARE DOUBLE BAGGED IN ORDER TO PREVENT THE DEBRIS FROM CLINGING TO THE BAG WHILE THE SYRINGES ARE LOADED INTO THE MACHINE HOPPER. IN THE EVENT MANUFACTURING PERSONNEL FAIL TO FOLLOW ESTABLISHED MANUFACTURING GUIDELINES, CARDBOARD CAN BE TRANSFERRED INTO THE FINISHED GOODS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS WERE FOUND BEFORE USE WITH CARDBOARD IN THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 TRAYS WERE DISCOVERED TO HAVE CARDBOARD IN THEM."

    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 3 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAYS WERE FOUND BEFORE USE WITH CARDBOARD IN THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3 TRAYS WERE DISCOVERED TO HAVE CARDBOARD IN THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690152 BD LUER-LOK SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 9060739 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other