BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BD NEEDLE

    MDR report key: 18920283 · Received March 18, 2024

    Report

    Report Number
    3002682307-2024-00054
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    February 15, 2024
    Report Date
    April 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903006373
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    PR (B)(4) - FOLLOW UP MDR FOR CORRECTION. AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. AFTER FURTHER REVIEW IT WAS CONFIRMED THAT THE PRODUCT WAS NOT USED ON A HUMAN BUT ON AN ANIMAL AND COMPLETED. MFR#: 3002682307- 2024-00054 IS VOID AS A RESULT.

    Description of Event or Problem · 0

    GOOD MORNING I AM EMAILING TO REPORT A FAULTY NEEDLE THAT ONE OF OUR VETS HAD THE MISFORTUNE OF USING TODAY. THE NEEDLE BROKE OFF ONCE INSERTED INTO A HORSE. AS YOU CAN IMAGINE, THIS IS NOT AN IDEAL SITUATION. PLEASE CAN YOU ADVISE US OF THE COURSE OF ACTION THAT NEEDS TO BE TAKEN? THE NEEDLE IN QUESTION IS A 16G X 1 1/2, LOT 220523. I LOOK FORWARD TO YOUR RESPONSE. MANY THANKS LUCKILY, ON THIS OCCASION, THERE WAS NO SERIOUS IMPACT TO THE PATIENT AS THE VET FELT THE NEEDLE SNAP AND ACTED QUICKLY AND EFFICIENTLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181967 UNKNOWN BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 220523 00382903006373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown