BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 12249291 · Received July 29, 2021

    Report

    Report Number
    3003152976-2021-00434
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    September 2, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-27. H6: INVESTIGATION SUMMARY ONE PHYSICAL SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A HARD BROWN AND FIBROUS PARTICLE COVERED IN THE LUBRICANT USED IN THE BARREL WAS OBSERVED INSIDE THE SYRINGE. USING MAGNIFICATION, THE PARTICLE APPEARED TO BE BURNT MATERIAL WHICH CAN GENERATE DURING THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2101038, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE AND INJECTION MACHINES ARE RAN PRIOR TO USE TO REMOVE ANY EXCESS MATERIALS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THIS DEFECT CAN OCCUR DUE TO BURNT MATERIAL GENERATING DURING THE MOLDING PROCESS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A STAIN INSIDE OF IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING EPIDURAL SYRINGES IT WAS NOTED THAT ONE PLASTIPAK 20 ML SYRINGE CONTAINED A STAIN PARTICLE INSIDE THE SYRINGE. THIS IS VERY ALARMING CONSIDERING THAT THE CONTENT OF THE SYRINGE IS MEANT TO BE ADMINISTERED FOR EPIDURAL SPACE.".

    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 THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE HAD A STAIN INSIDE OF IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN PREPARING EPIDURAL SYRINGES IT WAS NOTED THAT ONE PLASTIPAK 20 ML SYRINGE CONTAINED A STAIN PARTICLE INSIDE THE SYRINGE. THIS IS VERY ALARMING CONSIDERING THAT THE CONTENT OF THE SYRINGE IS MEANT TO BE ADMINISTERED FOR EPIDURAL SPACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142344 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2101038

    Patients

    Seq Age Sex Outcome Treatment
    1