BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HOME SHARPS CONTAINER

    MDR report key: 9538981 · Received January 2, 2020

    Report

    Report Number
    2243072-2019-02933
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 8, 2020
    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. AS PER DHR COMPLETED BY MANUFACTURING, ¿NO NCR¿S WERE RAISED DURING THE PRODUCTION OF THIS LOT. ALL TESTING WAS WITHIN SPECIFICATION.¿ H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD HOME SHARPS CONTAINER NEEDLE WILL NOT FIT INTO THE CONTAINER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. 9213001 IT WAS REPORTED THAT SHE CAN NOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN CONTAINER. HAS TO USE SCREWDRIVER TO PUSH INSIDE. ISSUE: CONSUMER REPORTED SHE CANNOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN THIS CONTAINER, SHE HAD TO USE SCREWDRIVER TO PUSH. HER HUSBAND ORDERS HER CONTAINERS, SHE IS NOT SURE WHICH SIZE HE HAD ORDERED IN THE PAST. EXPLAINED THIS CONTAINER MAY NOT BE COMPATIBLE FOR NEEDLES TO DISPOSE. EXPLAINED TO CHECK WITH THE SUPPLIERS TO SEND THE THE RIGHT SIZE SHE WAS GETTING IN THE PAST.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. MEDICAL DEVICE EXPIRATION DATE: N/A. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. 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 WAS REPORTED THAT BD HOME SHARPS CONTAINER NEEDLE WILL NOT FIT INTO THE CONTAINER. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 323487 BATCH NO. 9213001. IT WAS REPORTED THAT SHE CAN NOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN CONTAINER. HAS TO USE SCREWDRIVER TO PUSH INSIDE. ISSUE: CONSUMER REPORTED SHE CANNOT DISPOSE THE NEEDLE FROM HER INSULIN PUMP IN THIS CONTAINER, SHE HAD TO USE SCREWDRIVER TO PUSH. HER HUSBAND ORDERS HER CONTAINERS, SHE IS NOT SURE WHICH SIZE HE HAD ORDERED IN THE PAST. EXPLAINED THIS CONTAINER MAY NOT BE COMPATIBLE FOR NEEDLES TO DISPOSE. EXPLAINED TO CHECK WITH THE SUPPLIERS TO SEND THE RIGHT SIZE SHE WAS GETTING IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4697 BD HOME SHARPS CONTAINER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9601 9213001 10885403960109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other