BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 20844603 · Received December 4, 2024

    Report

    Report Number
    1911916-2024-00870
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 26, 2024
    Report Date
    January 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    (B)(4) FOLLOW UP: IT WAS REPORTED THE NEEDLE EXTENDER HAS BEEN LEAKING. TO AID IN THE INVESTIGATION, ONE PHOTO AND ONE VIDEO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE VIDEO SHOWS A NEEDLE ASSEMBLY OUT OF THE PACKAGING BLISTER, WITH NO PLASTIC SHIELD, AND ASSEMBLED TO A SYRINGE EXTENSION. WHILE EXPELLING THE SOLUTION, THERE IS A LEAK. THE PHOTO PROVIDED SHOWS THE SIDE OF A PACKAGING SHELF BOX. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO OR VIDEO. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    MATERIAL#: 305127. BATCH NUMBER#: UNKNOWN. VERBATIM#: PLEASE FIND ATTACHED THE NEEDLE EXTENDER VIDEO OF THE LEAK THAT I EITHER MENTIONED TO YOU OR ROB A MONTH OR 2 AGO. I HAVE ALSO ATTACHED THE NEEDLES THAT THEY ARE USING. IF YOU COULD KINDLY HELP US TROUBLE SHOOT AS IT HAS BEEN LEAKING FOR ALMOST LAST 1 YEAR AND WE JUST BOUGHT IT LAST YEAR

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT - WE ARE LOSING ABOUT 2ML OUT OF 5ML OF WHATEVER IS BEING INJECTED DUE TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681568 NEEDLE 25X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON UNKNOWN 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown