BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5"

    MDR report key: 13415396 · Received February 1, 2022

    Report

    Report Number
    3002682307-2022-00027
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 14, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. INITIAL REPORTER ADDR 1: (B)(6). 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304000 AND LOT NUMBER 210335. 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, RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE ASSEMBLED WITH A CAVERJET SYRINGE BY FOLLOWING THE CAVERJET KIT INSTRUCTIONS. THE NEEDLE HUB WAS PLACED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE RETAINED SAMPLES PRESENTED ANY SIGNS OF DEFECT AND ALL CONNECTIONS WERE ACCEPTABLE WITH NO SIGNS OF LEAKAGE. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. TAKING INTO ACCOUNT THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE REPORTED INCIDENT RESULTED FROM DEFECTIVE LUER DIMENSIONS, DAMAGE TO THE SYRINGE TIP, OR AN INSUFFICIENT ADJUSTMENT BETWEEN THE TWO DEVICES. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE IT IS HIGHLY UNLIKELY THAT THIS ISSUE RESULTED FROM DAMAGE TO THE NEEDLE PRODUCT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5" HAD THE NEEDLE AND SYRINGE SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE NEEDLE DETACHES FROM THE SYRINGE DURING THE INJECTION¿.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5" HAD THE NEEDLE AND SYRINGE SEPARATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THE NEEDLE DETACHES FROM THE SYRINGE DURING THE INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447120 BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5" HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 210335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown