BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 18771367 · Received February 23, 2024

    Report

    Report Number
    3002682307-2024-00033
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 1, 2024
    Report Date
    June 27, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBER ADDED TO MATERIAL GRID REPORTED ON 14 FEB 2024.

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE DISPLAYED A CANNULA WITH A ROUNDED PARTICLE IN THE FLUID PATHWAY. AS THE PHYSICAL SAMPLE WAS NOT AVAILABLE, WE WERE UNABLE TO IDENTIFY THE MATERIAL. HOWEVER, CONSIDERING THE PROVIDED FEEDBACK, IT IS UNDERSTOOD THAT THE PARTICLE WAS A PIECE OF METAL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBERS 231008 AND 231105. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE FINAL PRODUCT PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. DURING THE SUB-ASSEMBLY CANNULA PRODUCTION PROCESS, OCCURRENCES OF METALLIC PARTICLES WERE DETECTED AND ACTIONS WERE TAKEN TO MITIGATE THIS DEFECT. METAL PARTICLES MAY ARISE FROM AN INTERNAL DIAMETER SCRATCH THAT IS GENERATED IN THE DRAWING PROCESS DURING MANUFACTURE. THE DRAWING PROCESS IS RESPONSIBLE FOR RECEIVING THE WELDED CANNULA TUBE AND DRAWING IT CONTINUOUSLY UNTIL IT REACHES THE RIGHT SPECIFICATIONS FOR EXTERNAL DIAMETER, WALL THICKNESS, AND VISUAL APPEARANCE. THE PLUG IS PLACED INSIDE THE CANNULA TUBE WITH AN OIL LUBRICATION TO PREVENT DAMAGE TO THE INTERNAL DIAMETER, DAMAGE WHICH COULD CAUSE THE INTERNAL DIAMETER TO BE SCRATCHED AND GENERATE METAL PARTICLES. SEVERAL ACTIONS HAVE BEEN TAKEN TO MITIGATE THIS ISSUE, INCLUDING ACQUISITION OF A PROFILE PROJECTOR TO MEASURE THE ANGLES AND DIAMETER OF THE PLUGS, TRAINING OF ALL ASSOCIATES INVOLVED IN THE DRAWING PROCESS, UPDATES PROCEDURES TO THE OIL CART FEED FUNNEL AND SUPPLY CART, IDENTIFICATION OF ALL DRUMS FOR A BETTER VISUALIZATION OF THE CLEAN OIL STORED, AND ACQUISITION OF A NEW PLUG CLEANING MACHINE AND A NEW MICROSCOPE FOR CLEANING AND INSPECTING THE APPEARANCE OF THE PLUG. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLE HAS METAL IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOW REPEATEDLY EXPERIENCED THAT THE NEEDLES FROM YOU (IT IS CURRENTLY ONLY ABOUT BD MICROLANCE 3, 18G) CONTAIN SMALL PIECES OF METAL, AS SHOWN IN THE PICTURE ATTACHED. WE USE THIS NEEDLE TO DRAW UP MEDICINE (BOTH VIA GLASS AMPOULE AND VIAL). THIS IS OF COURSE NOT REASSURING FOR ANYONE, AND THEREFORE THIS INQUIRY. CLEAR METAL PART IN THE NEEDLE, PLEASE SEE ATTACHED PICTURE. WHEN DID THE INCIDENT OCCUR? DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238042 BD CONVENTIONAL NEEDLE NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 231105

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown