BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 8515065 · Received April 15, 2019

    Report

    Report Number
    3002682307-2019-00253
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 22, 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: ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. BD HAS BEEN PROVIDED WITH ONE PACKED SAMPLE OF LOT 180906. EXAMINATION SHOW A PIECE OF GREEN PLASTIC ON HUB WHICH CONSIST ON A PIN RACK. BD HAS CONCLUDED THAT THIS FOREIGN MATTER CONSISTS A PIECE OF PIN RACK IN HUB COMING FROM THE ASSEMBLING NEEDLE MACHINE. IN ORDER TO MOVE THE PIECES THROUGH THE ASSEMBLING PROCESS, THE NEEDLES ARE LOCATED IN SOME PLASTIC RACKS MADE OF GREEN POLYCARBONATE. CONSIDERING OUR EXPERIENCE, OUR OPINION IS THAT ONE OF THESE "RACK PINS" MAY BREAK BECAUSE OF ANY BLOCKAGE IN THE MANUFACTURING PROCESS REMAINING ATTACHED TO THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE WAS A REDDISH FOREIGN MATER ON THE NEEDLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TO FRENCH TO ENGLISH: WHEN PREPARING THE MEDICAL CARE, THE INTEGRITY OF THE NEEDLE IS NOT COMPLIANT. THE NEEDLE HAS A REDDISH ASPECT.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE WAS A REDDISH FOREIGN MATER ON THE NEEDLE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TO (B)(6) TO ENGLISH: WHEN PREPARING THE MEDICAL CARE, THE INTEGRITY OF THE NEEDLE IS NOT COMPLIANT. THE NEEDLE HAS A REDDISH ASPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308983 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 180906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other