BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 9528103 · Received December 27, 2019

    Report

    Report Number
    3003152976-2019-00888
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 12, 2019
    Report Date
    February 3, 2020
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A TOTAL OF NINE SAMPLES AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, FIBERS WERE OBSERVED INSIDE THE SYRINGE. USING MAGNIFICATION, THE FIBERS WERE IDENTIFIED TO BE POLYPROPYLENE PARTICLES. THESE PARTICLES GENERATE DURING THE TRANSPORT AND MOLDING PROCESS OF THE PIECES IN THE MANUFACTURING EQUIPMENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811230, 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 AND MACHINES ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL 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 BEFORE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM THE LEAD QA FOR OUR ASEPTIC UNIT AND WE HAVE IDENTIFIED SOME FAILED 30ML SYRINGES DURING OUR PREPARATION STAGE IN ASEPTIC PRODUCTION. PRODUCT REFERENCE 301229 (30ML BD LUER-LOK SYRINGES) BATCH NUMBER: 1909206 WE HAVE CURRENTLY IDENTIFIED NINE AFFECTED SYRINGES FROM TWO BOXES OF THIS BATCH NUMBER, WITH A FURTHER THREE BOXES AWAITING TO BE USED IN OUR UNIT, WHICH WE HAVE QUARANTINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM THE LEAD QA FOR OUR ASEPTIC UNIT AND WE HAVE IDENTIFIED SOME FAILED 30 ML SYRINGES DURING OUR PREPARATION STAGE IN ASEPTIC PRODUCTION. PRODUCT REFERENCE 301229 (30 ML BD LUER-LOK SYRINGES) BATCH NUMBER: 1909206 WE HAVE CURRENTLY IDENTIFIED NINE AFFECTED SYRINGES FROM TWO BOXES OF THIS BATCH NUMBER, WITH A FURTHER THREE BOXES AWAITING TO BE USED IN OUR UNIT, WHICH WE HAVE QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322757 BD PLASTIPAK LUER-LOK 30 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1909206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other