BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9716770 · Received February 17, 2020

    Report

    Report Number
    1213809-2020-00096
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 26, 2020
    Report Date
    March 9, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DEPICTED A LOOSE 1ML LL SYRINGE. THE BARREL WAS OBSERVED TO HAVE SEVERAL SMALL PARTICLES POTENTIALLY EMBEDDED IN THE WALL OPPOSITE 0.4, 0.5 AND POSSIBLY 0.7ML MARKINGS. DUE TO THE PHOTO BEING OUT OF FOCUS IT WAS NOT POSSIBLE TO IDENTIFY THE FOREIGN MATTER PARTICLES, HOW MANY THERE WERE, NOR THEIR SIZE. A PHYSICAL SAMPLE OR ADDITIONAL PHOTOS ARE REQUIRED TO IDENTIFY THE FM. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8211583 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RED PARTICLES WERE FOUND EMBEDDED IN THE BD SYRINGE LUER-LOK¿ TIP PLASTIC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A COMPLAINT ABOUT RED PARTICLES IN A 1 ML SYRINGE USED BY US AND PREPARED A TRANSPARENT COLOR PREPARATION." "THE PARTICLES APPEAR TO BE EMBEDDED IN THE PLASTIC THAT KIND OF MADE 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 THAT RED PARTICLES WERE FOUND EMBEDDED IN THE BD SYRINGE LUER-LOK¿ TIP PLASTIC DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED A COMPLAINT ABOUT RED PARTICLES IN A 1 ML SYRINGE USED BY US AND PREPARED A TRANSPARENT COLOR PREPARATION." "THE PARTICLES APPEAR TO BE EMBEDDED IN THE PLASTIC THAT KIND OF MADE THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181956 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 8211583 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other