BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME SHARPS CONTAINER

    MDR report key: 8617443 · Received May 16, 2019

    Report

    Report Number
    2243072-2019-00941
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    10885403960109
    PMA / PMN Number
    K943139
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. UNABLE TO PERFORM DHR CHECK DUE TO UNKNOWN LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOME SHARPS CONTAINER WAS UNABLE TO FIT A PEN NEEDLE WITH A COVER INSIDE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. UNKNOWN VERBATIM: CONSUMER REPORTED HE HAD DIFFICULTY DETACHING THE PEN NEEDLE IN THE SHARP CONTAINER. INSTRUCTED HOW TO REMOVE THE PEN NEEDLE FROM THE CONTAINER. HE WAS UNABLE TO DETACH THE PEN NEEDLE. ASSISTED CONSUMER TO HELP REMOVING THE PEN NEEDLE FROM THE CAP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6), USA HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS PREMIUM PLASTIC SOLUTIONS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME SHARPS CONTAINER WAS UNABLE TO FIT A PEN NEEDLE WITH A COVER INSIDE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487, BATCH NO. UNKNOWN. VERBATIM: CONSUMER REPORTED HE HAD DIFFICULTY DETACHING THE PEN NEEDLE IN THE SHARP CONTAINER. INSTRUCTED HOW TO REMOVE THE PEN NEEDLE FROM THE CONTAINER. HE WAS UNABLE TO DETACH THE PEN NEEDLE. ASSISTED CONSUMER TO HELP REMOVING THE PEN NEEDLE FROM THE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407844 HOME SHARPS CONTAINER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other