BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8252916 · Received January 16, 2019

    Report

    Report Number
    3003152976-2018-00593
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 31, 2018
    Report Date
    March 5, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE SAMPLES WERE RECEIVED BY OUR QUALITY ENGINEER TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLES, SMALL PARTICLES WERE OBSERVED INSIDE THE BLISTER, OUTSIDE OF THE SYRINGE. NO DAMAGE OR MOLDING DEFECTS WERE NOTED. FURTHER INSPECTION DETERMINED THE PARTICLES CONSISTED OF POLYPROPYLENE PRESENT IN TWO OF THE SAMPLES AND A PAPER PARTICLE IN THE THIRD. NO FOREIGN MATTER WAS OBSERVED WITHIN THE FLUID PATH. 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. IT IS LIKELY THE POLYPROPYLENE ORIGINATED FROM THE MOLDING PROCESS WHILE THE PAPER PARTICLES ORIGINATED FROM THE BLISTER DURING PACKAGING. MACHINES ROUTINELY UNDERGO PROPER MAINTENANCE AND CLEANING. A VACUUM SYSTEM WAS RECENTLY IMPLEMENTED TO REDUCE ANY FOREIGN MATTER INSIDE THE PRODUCT BLISTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH 61 SYRINGES WITH WHITE FIBERS, 1 WITH BLACK FIBER AND 1 WITH DAMAGE/POLLUTION ON TOP OF THE SYRINGE.

    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 WITH THE USE OF THE BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE THERE WAS AN ISSUE WITH 61 SYRINGES WITH WHITE FIBERS, 1 WITH BLACK FIBER AND 1 WITH DAMAGE/POLLUTION ON TOP OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47569 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other