BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE

    MDR report key: 9112443 · Received September 24, 2019

    Report

    Report Number
    3002682307-2019-00514
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 1, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS BEEN PROVIDED WITH PHOTOS AND SAMPLES FOR CATALOG 303129; LOT 190608 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTOS AND SAMPLE IDENTIFIED WAS EPOXY THAT DROPPED ON THE CANNULA SURFACE OF THE NEEDLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BASED ON BD¿S EXPERIENCE, THIS ISSUE OCCURRED IN THE ASSEMBLY PROCESS IN WHICH THE ADHESIVE IS ADDED TO THE HUB BECAUSE OF SOME TEMPORARY STOPPAGE IN THE PROCESS OR ANY READJUSTMENT OF THE EPOXY DOSAGE MACHINE. CONSEQUENTLY, HIGHER QUANTITIES OF EPOXY WERE ADDED, AND IT FELL TO NEXT CANNULA (THE REPORTED ONE) RESULTING IN THE OBSERVED ISSUE. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I RECEIVED A NEEDLE FROM THE OR WHERE EXACTLY MOLTEN PLASTIC IS PRESENT ON THE NEEDLE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I RECEIVED A NEEDLE FROM THE OR WHERE EXACTLY MOLTEN PLASTIC IS PRESENT ON THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907764 BD BLUNT FILL NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 190608

    Patients

    Seq Age Sex Outcome Treatment
    1 Other