BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 8994541 · Received September 11, 2019

    Report

    Report Number
    3002682307-2019-00496
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 27, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000, LOT 180319, TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD MICROLANCE¿ NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE LIQUID CAME OUT FROM THE SYRINGE IN THE NEEDLE INSERTION ZONE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD MICROLANCE¿ NEEDLE HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE LIQUID CAME OUT FROM THE SYRINGE IN THE NEEDLE INSERTION ZONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783762 BD MICROLANCE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other