BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿3 NEEDLE

    MDR report key: 17367504 · Received July 20, 2023

    Report

    Report Number
    3002682307-2023-00201
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 28, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304622 AND LOT NUMBER 220919. 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 NEITHER PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED INCIDENT. WITH THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. 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. SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE¿3 NEEDLE THE NEEDLE BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: I AM REPORTING A QUALITY DEFECT ON A BD MICROLANCE 3 18G X 40 MM NEEDLE REF (B)(4), LOT 220919 PER 08/2027: WHEN HANDLING THE SOLVENT AND INJECTING IT INTO THE ANTIBIOTIC VIAL, THE NEEDLE BROKE AT THE PLASTIC LEVEL. I HAVE THE NEEDLE AT YOUR DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616895 BD MICROLANCE¿3 NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220919

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown