BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE NEEDLES

    MDR report key: 20629025 · Received November 7, 2024

    Report

    Report Number
    3002682307-2024-00238
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    July 19, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903010004
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301000 AND LOT NUMBER 220922. 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 OF THE SAME LOT NUMBER WERE OBTAINED FOR EVALUATION BY OUR QUALITY TEAM. THE RETAINED SAMPLES WERE ASSEMBLED WITH A BD EMERALD 2ML SYRINGE BY FOLLOWING REGULAR PRACTICES. THE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED SAMPLES DISPLAYED ANY SIGNS OF DEFECT AND NO LEAKAGE WAS OBSERVED. BASED ON THE INVESTIGATION RESULTS, AN EXACT MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED AT THIS TIME. ALTHOUGH THESE ARE NOT CONFIRMED CAUSES, IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM A DEFECTIVE CONNECTION DUE TO DEFECTIVE LUER DIMENSIONS OR DAMAGE TO THE SYRINGE OR CONNECTOR TIP. IT IS ALSO POSSIBLE THAT THE INCIDENT COULD BE RELATED TO AN INSUFFICIENT ADJUSTMENT BETWEEN THE TWO DEVICES DURING USE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE IT IS UNLIKELY THAT THE REPORTED INCIDENT RESULTED FROM A DAMAGED NEEDLE. 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. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 19TH JULY 2024, DURING MANUFACTURING OF LPS240719C-03 IN OUR DISTRIBUTION ISOLATOR OUR TECHNICIANS DETECT A SPILLAGE OF A SMALL QUANTITY OF SOLUTION BETWEEN THE MICROLANCE NEEDLE (INTERNAL BATCH MIC230612A, SUPPLIER LOT 220922 WITH AN EXPIRY DATE OF 31 AUG 2027) AND THE CONNECTOR WITH THE CATHIVEX FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49069 BD MICROLANCE NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 220922 00382903010004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown