BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE

    MDR report key: 20150952 · Received September 5, 2024

    Report

    Report Number
    3002682307-2024-00174
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 13, 2024
    Report Date
    November 12, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE PROVIDED INFORMATION, WE UNDERSTAND THAT AN ISSUE WITH CLOGGED NEEDLE OCCURRED. WE WOULD LIKE TO INFORM YOU THAT THE NEEDLES ARE ROUTINELY INSPECTED FOR OCCLUDED CANNULA CONDITION AS PART OF THE IN-PROCESS INSPECTIONS AFTER ASSEMBLY. IT SHOULD BE TAKEN INTO CONSIDERATION THAT THE MEDICATION USED MAY HAVE SOME IMPLICATION IN THIS REPORTED ISSUE. IN CERTAIN CIRCUMSTANCES, THE DRUG PRODUCT CAN BECOME DEPOSITED INSIDE THE CANNULA, CAUSING THE NEEDLE TO BLOCK/OCCLUDE DUE TO CRYSTALLIZATION OR OTHER SOLUBILIZATION EFFECTS. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. THEREFORE, THE HANDLING OF THE PRODUCT CANNOT BE DISCARDED AS A POSSIBLE CAUSE FOR THIS INCIDENT. IF THIS ISSUE WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW ANY AFFECTED SAMPLES. REGARDING THE COMMENT ¿¿OUR NEUROLOGIST ASKED TO FIND OUT IF THE MANUFACTURER OF THE NEEDLES HAS CHANGED¿ WE WOULD LIKE TO INFORM YOU NO CHANGE HAS BEEN PERFORMED. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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 MICROLANCE NEEDLE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR CUSTOMER MADE COMPLAINT, PLEASE SEE BELOW. ¿OUR NEUROLOGIST ASKED TO FIND OUT IF THE MANUFACTURER OF THE NEEDLES HAS CHANGED. HE USES A MICROLANCE, SMALL YELLOW, 0.3 X 13 MM. HE SAID THAT DILUTED SOLOMET DOES NOT ALWAYS GO THROUGH THE NEEDLE PROPERLY, IT CLUMPS. OTHER MEDICINAL SUBSTANCES GO YES AND THIS DOES NOT HAPPEN WITH ALL NEEDLES., WITH THIS MODEL. HAS ANYONE ELSE HAD QUESTIONS ABOUT THIS? OR THERE IS SOMETHING ELSE WRONG.¿ WOULD YOU PLEASE ADVICE WHAT INFORMATION IS NEEDED MORE, THANK YOU. 26 AUG: ¿NEUROLOGIST SAID THAT THIS HAPPENS IN SEVERAL NEEDLES AND HE ALSO CHANGES THE PACKAGING SEVERAL TIMES, SO I DON'T THINK THIS IS A PROBLEM WITH JUST ONE BOX. BUT I'LL TAKE A MESSAGE TO HIM AND GET BACK TO YOU. HE IS A NEUROLOGIST WHO TREATS CLIENTS WITH MIGRAINES, HE USES BOTOX FOR TREATMENT, WITH WHICH HE HAS HAD NO PROBLEMS, IN ADDITION, HE USES SOLOMET BUPIVACAINE DILUTED, THIS CAUSES PROBLEMS, WHICH I HAVE SENT YOU A MESSAGE ABOUT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141122 BD MICROLANCE NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. UNKNOWN 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown