BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS CONTAINER

    MDR report key: 7938547 · Received October 5, 2018

    Report

    Report Number
    2243072-2018-01421
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 7, 2018
    Report Date
    December 17, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT TWO SMALL TABS OF LID OF THE NEEDLE CONTAINER ARE EASY TO CLOSE BUT THE WHITE, BIG ONE CAN BE EASILY OPENED FORCE REQUIRED FOR LID PULL OFF IS TO BE GREATER THAN 8 LBS. A REVIEW OF THE COMPLAINT WAS PERFORMED BY THE SUPPLIER AND ONCE SAMPLE WERE RECEIVED ALL CAP PULL OFF TESTS WERE GREATER THAN 8LBS. NO CAPA IS NEEDED AT THIS TIME BECAUSE ALL SAMPLES RECEIVED PASSED BDSDS REQUIRED CAP PULL OFF TESTS OF 8LBS OR GREATER. DHR REVIEW SHOWS NO NCR¿S WERE RAISED DURING THE PRODUCTION OF THIS LOT. ALL TESTING WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SHARPS CONTAINER THERE WAS AN ISSUE WITH THE LID OPENING TO EASILY. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS PREMIUM PLASTIC SOLUTIONS, LLC. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 WITH THE USE OF THE BD¿ SHARPS CONTAINER THERE WAS AN ISSUE WITH THE LID OPENING TO EASILY. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778230 BD¿ SHARPS CONTAINER SHARPS COLLECTOR MMK BECTON DICKINSON 7263001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other