BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 8848115 · Received July 31, 2019

    Report

    Report Number
    3002682307-2019-00426
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 12, 2019
    Report Date
    July 15, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 180312. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-15. MEDICAL DEVICE LOT #: 171108. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. DEVICE MANUFACTURE DATE: 2017-11-08. INVESTIGATION SUMMARY: SINCE COMPLAINT IS NOT POSSIBLE TO CONFIRM AND NO ISSUES WERE FOUND IN DHR, IT WAS DETERMINE THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROLANCE¿ NEEDLE LEAKED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN CONNECTING THE SYRINGE AND A SMALL NEEDLE, THERE WAS A LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639386 BD MICROLANCE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other