BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17406774 · Received July 27, 2023

    Report

    Report Number
    3002682307-2023-00212
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 5, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300637 AND LOT NUMBER 230115. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR (4) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A BROKEN HUB ASSEMBLED TO A LUER-LOCK SYRINGE WAS OBSERVED. AT THIS TIME, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THE BROKEN NEEDLE.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEBD MICROLANCE¿ 3 NEEDLE BROKE WHILE DRAWING FLUID FOR VIAL. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VERBATIM: O THE NEEDLE BROKE AFTER DRAWING A VOLUME OF 50 ML.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEBD MICROLANCE¿ 3 NEEDLE BROKE WHILE DRAWING FLUID FOR VIAL. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VERBATIM: O THE NEEDLE BROKE AFTER DRAWING A VOLUME OF 50 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323955 BD MICROLANCE¿ 3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 230115

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown