BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE CONVENTIONAL NEEDLES

    MDR report key: 19548241 · Received June 17, 2024

    Report

    Report Number
    3002682307-2024-00136
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 21, 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
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 230301. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY (20) RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR REVIEW. THE NEEDLES WERE INSPECTED FOR DIFFERENCE IN COLOR; HOWEVER, NO SIGNS OF VARIATION IN COLOR. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. REGARDING THE REPORT OF VARIATION IN COLOR, REGRETTABLY WITH THIS INFORMATION DEFECT CANNOT BE CONFIRMED NEITHER A ROOT CAUSE FINDING RELATED WITH THE MANUFACTURING OF THE PRODUCT CAN BE ESTABLISHED. IF THIS ISSUE WERE TO REOCCUR, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THE AFFECTED SAMPLE. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE CONVENTIONAL NEEDLES NEEDLE IS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE THAT WE'RE USING FOR EYE INJECTION HAS BEEN HAVING ISSUES, THE SHAFT COLOR IS VISIBLY NOT UNIFORM (THERE'S A PART THAT IS DARKER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323722 BD MICROLANCE CONVENTIONAL NEEDLES NEEDLE, HYPODERMIC FMI BECTON DICKINSON, S.A. 230301 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown