BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FILTER NEEDLE

    MDR report key: 8709222 · Received June 18, 2019

    Report

    Report Number
    1911916-2019-00594
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 27, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE (1) SAMPLE AND ONE (1) PHOTO WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED SAMPLE AND PHOTO IDENTIFIED THAT THE WHITE FOREIGN MATTER REPORTED BY THE CUSTOMER WAS EPOXY DRIP OVER ON THE NEEDLES/NEEDLE HUBS. EPOXY IS USED IN ADHERING THE CANNULA TO THE NEEDLE HUB AND IS PART OF THE NORMAL PRODUCTION PROCESS. VISUAL INSPECTION OF THE RETURNED SAMPLE AND PHOTO IDENTIFIED THAT THE WHITE FOREIGN MATTER REPORTED BY THE CUSTOMER WAS EPOXY DRIP OVER ON THE NEEDLES / NEEDLE HUBS. AN EPOXY DRIP OVER GENERALLY OCCURS WHEN THE EPOXY APPLICATOR FAILS TO SHUT OFF FOR A MISSING CANNULA. THERE ARE SEVERAL CONTRIBUTING / POSSIBLE FACTORS. A DIRTY SENSOR THAT DOESN¿T SHUT THE EPOXY OFF FOR A MISSING CANNULA. THE EPOXY PRESSURE IS TOO HIGH. THE EPOXY APPLICATOR NEEDS ATTENTION ¿ IT ISN¿T SHUTTING OFF WHEN IT SHOULD. THE EPOXY VISCOSITY IS ALSO RELATED TO TEMPERATURE FLUCTUATIONS. IF THE TEMPERATURE GOES UP, THE EPOXY GETS THINNER AND FLOWS FASTER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD FILTER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "COMPLAINT DESCRIPTION: ON 10-MAY-2019, THE REPORTER CONTACTED VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF EYLEA BECAUSE THE FILTER NEEDLE HAD ¿WHITE STUFF¿ ON IT. SHE REPORTED THE FOREIGN MATTER WAS LOCATED BOTH IN AND ON THE HUB OF THE NEEDLE. BD COMPONENT LOT AFFECTED: BD 19G FILTER NEEDLE CATALOG #: 305200 LOT #: 8172962."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 OCCURRED BEFORE USE WITH A BD FILTER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "COMPLAINT DESCRIPTION: ON 10-MAY-2019, THE REPORTER CONTACTED VIA PHONE TO REQUEST REPLACEMENT OF 1 VIAL OF EYLEA BECAUSE THE FILTER NEEDLE HAD ¿WHITE STUFF¿ ON IT. SHE REPORTED THE FOREIGN MATTER WAS LOCATED BOTH IN AND ON THE HUB OF THE NEEDLE. BD COMPONENT LOT AFFECTED: BD 19G FILTER NEEDLE CATALOG #: 305200, LOT #: 8172962".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503903 BD FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BECTON DICKINSON AND COMPANY 8172962 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other