BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16548538 · Received March 15, 2023

    Report

    Report Number
    1213809-2023-00202
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 22-MAR-2023 . H6: INVESTIGATION SUMMARY FOUR SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THREE SAMPLES HAD VERTICAL CRACK NEAR THE TIP OUTSIDE THE PRINT AREA EXTENDING FROM BELOW THE 2ML GRAD LINE ALL THE WAY TO THE 5ML GRAD LINE. ONE SAMPLE HAD A CIRCULAR HOLE THAT WAS OUTSIDE THE PRINT AREA LOCATED BETWEEN THE 2ML AND 3ML GRAD LINES. ADDITIONALLY, IT WAS OBSERVED THAT ONE OF THE SAMPLES HAD A PIECE OF A PLASTIC MOST LIKELY SHRED OF BROKEN HOLE THAT APPEARED INSIDE THE SYRINGE. POTENTIAL ROOT CAUSE FOR THE DAMAGED/ CRACKED BARRELS DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2140602. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE DAMAGED WITH A HOLE BROKEN IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE HAS A HOLE BROKEN IN THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE DAMAGED WITH A HOLE BROKEN IN THE BARREL THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE HAS A HOLE BROKEN IN THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711340 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2140602 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown