BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE NEEDLE

    MDR report key: 13063072 · Received December 22, 2021

    Report

    Report Number
    3002682307-2021-00667
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 26, 2021
    Report Date
    March 8, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301900 AND LOT NUMBER 210801. 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, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. AT THIS TIME, A DEFINITIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE NEEDLE EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE FOR ASPIRATION, WITHOUT SAFETY PROTECTION HAS SOME FORM OF COLOR/PLASTIC CLICK ON THE "HEAD". DOES NOT SEEM TO AFFECT FUNCTION BUT FEELS UNCOMFORTABLE TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROLANCE NEEDLE EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE FOR ASPIRATION, WITHOUT SAFETY PROTECTION HAS SOME FORM OF COLOR/PLASTIC CLICK ON THE "HEAD". DOES NOT SEEM TO AFFECT FUNCTION BUT FEELS UNCOMFORTABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1966949 BD MICROLANCE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown