BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLE

    MDR report key: 9130520 · Received September 27, 2019

    Report

    Report Number
    3002682307-2019-00525
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 12, 2019
    Report Date
    October 10, 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

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOT 180319 TO INVESTIGATE FOR THIS RECORD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. WITH THE AVAILABLE INFORMATION PROVIDED, BD UNDERSTANDS A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE. BASED ON OUR EXPERIENCE, THIS ISSUE COULD BE POSSIBLE BECAUSE OF A DEFECTIVE CONNECTIVITY DUE TO A DEFECTIVE LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP, BUT IT COULD BE ALSO RELATED WITH THE HANDLING OF THE PRODUCT AS SOME INSUFFICIENT ADJUSTMENT BETWEEN OF THE DEVICES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD MICROLANCE¿ NEEDLE HAS BEEN FOUND WITH THE NEEDLE SEPARATING FROM THE SYRINGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN THE SYRINGE WAS INJECTED, IT DETACHED, BY PRESSING THE LIQUID, FROM THE NEEDLE, IN AN" EXPLOSIVE "WAY, DISCHARGING THE CONTENTS COMPLETELY.

    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 WITH THE NEEDLE SEPARATING FROM THE SYRINGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN THE SYRINGE WAS INJECTED, IT DETACHED, BY PRESSING THE LIQUID, FROM THE NEEDLE, IN AN" EXPLOSIVE "WAY, DISCHARGING THE CONTENTS COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925986 BD MICROLANCE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 180319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other